RU2757752C1 - Method for determining individual profile of total cardiovascular risk factors in patient of working age - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to preventive medicine of cardiovascular diseases (CVD), diagnosis, prediction and assessment of CVD risk and acute cardiovascular events (ACE) in patient of Russian population of working age. Anamnestic, clinical, instrumental and laboratory examinations of patient are carried out to identify values of the following causal risk factors (RF) of CVD: systolic blood pressure (SBP) at rest, mm Hg, heart rate (HR), beats/min, body mass index (BMI), g/cm2, stress angina status, acute myocardial infarction (AMI) in anamnesis, acute stroke (CVA) in the anamnesis, questionable ECG signs of coronary heart disease (CHD), reliably established ECG signs of CHD, smoking status separately for men and women, alcohol consumption status, low density lipoprotein (LDL) levels, mmol/l. The individual profile of patient's total risk factors for CVD (IPTR) is calculated at the time of examination. To do this, the value of each RF obtained during ranking is multiplied by the corresponding weighting factor. Results are summarized obtaining value of the patient's IPTR. Additionally, the presence of confirmed diagnosis of diabetes mellitus in patient is detected, or, in his absence, clinical, instrumental and laboratory studies are carried out for its detection in patient. Taking the value of the patient's IPTR as 100%, determine share in it - the contribution in % of each obtained products of individual values of RF to the weight coefficients, thus determining the personal profile of cardiovascular risk causal factors for this patient at the time of examination. The RF with the highest values in % is attributed to the main individual causal RF of CVD. Moreover, if patient has diabetes mellitus, it is also referred to as the main individual causal RF of this patient - requiring priority preventive or curative measures to reduce level of individual total cardiovascular risk in accordance with significance of identified causal RF in patient’s individual profile. The method provides individualization of the main causal risk factors for CVD in a particular patient, in contrast to the average population risk level. According to the contribution of specific risk factors of the patient to his total risk taking into account the population weight coefficients for each factor at the time of examination, the main causal factors of his individual total risk of MCVE are determined, which in next 10 years may probabilistically lead to development of fatal or non-fatal MCVE. Identification of the personal contribution of these factors or their combination to the individual total profile of risk factors of CVE in this patient is necessary for his motivation and targeted therapeutic and preventive effects and modification of these particular RF.

EFFECT: method provides individualization of the main causal risk factors for CVD in a particular patient.

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Description

The invention relates to preventive medicine of cardiovascular diseases, diagnosis, prediction and assessment of the risk of cardiovascular diseases (CVD) and acute cardiovascular events (OSS) in a patient in the next 10 years in order to form individual treatment and prophylactic recommendations for patients. The method allows to identify in a particular patient the main causal risk factors (RFs) inherent in him from those available to him, characteristic RFs for his population, in this case, the Russian one. The main causal factors of this patient, as well as their individual totality at the time of the examination, make the most significant personal contribution to the realization of his individual total risk of OSS in the next 10 years of his life. In the event of lifestyle changes, the implementation of preventive measures aimed specifically at these personal main RFs, over time, as a result of preventive or therapeutic measures, these controlled RFs can reduce their negative contribution to the development of non-fatal acute or fatal cardiovascular events (OCCS) and thereby reduce the total cardiovascular risk of the patient and prevent OCCS. Thus, the proposed assessment is dynamic and objective for a particular patient.

Known methods for assessing the individual total risk of CVD and fatal risk are a necessary component in the development of appropriate preventive recommendations for cardiovascular and cerebrovascular diseases, both at the population and personal levels. The purpose of determining the risk of CVD is to carry out a reliable predictive assessment of the likelihood of developing OSCC in the coming years in a patient (usually a period of 5 or 10 years). At the same time, the individual level of RF is measured and concomitant CVDs are objectified.

Many models and methods have been developed to assess the risk of developing CVD or OCCS.

The known method of individual quantitative assessment of the risk of developing clinical manifestations of atherosclerosis (patent RU 2385668 C2, publ. 10.04.2010, Bovtyushko V.G.). A mass examination of patients is carried out, with the determination of biochemical, immunological, physiological and clinical parameters. Discriminant analysis is performed. Weights are obtained for each indicator and a bias constant. The values of the integral indicator of the state of health for each examined patient are determined as the weighted sum of the values of all the indicators obtained, multiplied by the corresponding weight coefficient, and the bias constant added to it. Determine the dependence of the incidence rate on the value of the integral indicator. At the stage of using the method for any patient, values are determined from the same indicators as at the preliminary stage. On the basis of the obtained indicators, the value of the integral indicator is calculated with the weight coefficients and the displacement constant obtained at the preliminary stage. The incidence rate is determined according to the dependence of the incidence rate on the value of the integral health indicator, determined at the preliminary stage. The incidence rate is used to assess the risk of developing clinical manifestations of atherosclerosis.

However, the known method, despite the individual approach to the calculations, does not provide for the identification of individual main causal risk factors for OCCS, which make the greatest contribution to the total CV risk of a particular patient.

In the application US 2014136226 A1 (publ. 05.15.2014, Koninklijke Philips NV) a system for managing the state of cardiovascular health is disclosed for calculating a patient's risk indicator based on a treatment recommendation or lifestyle change. The system contains a number of devices that operate to calculate a risk parameter and a disease risk score based on recommended treatments or lifestyle changes. However, this does not allow to single out the main, most significant risk factors for the development of OSS for a particular patient from all the factors available to him.

Also known is a computerized interactive method and system for determining the risk of developing CVD and the consequences (US 6322504 B1, publ. 27.11.2001, R and T LLC). The patient is provided with ways to change risk and track progress as his risk factors change or persist. In a computerized way, questions are transmitted to an individual about disease risk factors; getting answers to questions; transmission of simultaneous feedback with responses; determining the risk of developing a disease in an individual or related consequences using at least one of the answers and practical recommendations for this disease; transmitting a summary of positive risk factors and information on risk modification to an individual; tracking changes in an individual's responses and positive risk factors over time. Positive risk factors (i.e., likely to lead to the development of CVD) include: male gender, postmenopausal woman and postmenopausal woman with removed ovaries, age of a man over 40, age of a woman over 45, BMI indicating overweight or obesity, smoking, diabetes mellitus, elevated levels of lipids and lipoproteins, coronary artery disease, peripheral vascular disease, lack of exercise, arterial hypertension, stress and anxiety, left ventricular hypertrophy, lack of antioxidant vitamins, high homocysteine levels, deficiency in folic acid, vitamins B6 or B12, low alcohol consumption, positive family history of coronary artery disease, lack of aspirin-cardio intake.

These known methods and systems provide monitoring of the patient's condition, its dynamics, taking into account all the CVD risk factors available to him. However, they do not provide information which of these many factors are the most important in order to prevent the realization of the patient's risks by modifying the individual total risk of a particular individual by means of a targeted targeted impact on them.

In the method disclosed in patent RU 2651708 C2 (publ. 04/23/2018, SOMALODZHIK, INC., US), it is proposed to determine the increased risk of OCCS in a particular patient. The method includes the determination of biomarkers MMP-12, complement C7, CCL18, complex of α-1-antichymotrypsin, GDF-11, α-2-antiplasmin and angiopoietin-2, and is suitable for a five-year period. This method serves the purposes of only risk diagnostics, forecasting, however, it does not provide data on what the most important personal risk factors should be influenced in the first place in order to prevent OCCS.

In the process of long-term prospective, randomized studies in the countries of the world, a number of scales for assessing the total cardiovascular risk have been created, which have proven their effectiveness. There are many scientific publications on their practical use (see, for example, on the SCORE and PROCAM scales - IV Osipova et al. Assessment of the total coronary risk in persons whose profession is associated with stress. // Cardiovascular Therapy and Prevention, 2008; 7 (6), pp. 33-37; on the assessment of the prognosis of the severity of complications in acute coronary syndrome GRACE (by 8 risk factors), TIMI (by 7 risk factors), SYNTAX (to assess the severity and prevalence of coronary atherosclerosis) - Kelekhsaev Kh. R. Dependence of angiographic characteristics of coronary artery disease on cardiovascular risk factors in patients with acute coronary syndrome, Ph.D., M., 2018, pp. 15-32; about Scandinavian Stroke Scale score - Thure Filskov Overvad et al Incidence and prognostic factors for recurrence of intracerebral hemorrhage in patients with and without atrial fibrillation: A cohort study. // Thromb Res. 2020 Jul; 191: 1-8.doi: 10.1016 / j.thromres.2020.03.024.Epub 2020 Apr 21. PMID: 32339765 DOI: 10. 1016 / j.thromres.2020.03.024).

Patent RU 2664150 C2 (publ. 15.08.2018, Gabinsky Ya.L.) deals with planning the prevention, monitoring and treatment of patients at risk or already suffering from CVD. To do this, the coronary status of a person is determined by determining the coronary code, presented in the form of a four-digit numerical record, determined by obtaining visual assessment of the state of the patient's coronary arteries using computed tomography, coronary angiography data, summary data on cardiovascular risk on the SCORE scale and data on factors CVD risk according to the additional scale of coronary risks EFIR, which contains: 1 - low-risk group, which includes patients who scored less than 5 points, and which has a value of 0; 2 - high-risk group, which includes patients who scored 5 or more points, and which has a value of 1. The points are calculated based on the assessment of indicators: fasting blood plasma glucose - 5.6-6.9 mmol / l - 1 point; increased C-reactive protein (> 5 mg / l) - 1 point; body mass index> 30 kg / m2 - 0.5 points; abdominal obesity (waist> 100 cm) - 1 point; high density lipoproteins <1.0 in men and <1.2 in women - 1 point; subclinical lesion of the carotid arteries (stenosis> 50%) - 0.5 points; hereditary history of early CVD in 1st-line relatives aged <45 in men, <55 years in women - 1 point; hypodynamia - 0.5 points; left ventricular hypertrophy - 0.5 points; professions associated with increased psycho-emotional overload - 1 point; marital status (single men) - 0.5 points; depression, assessed on the Beck scale - 0.5 points. They also use data on the presence of percutaneous coronary intervention and / or coronary artery bypass grafting, subsequent analysis of the data obtained by mathematical methods using software. Receive the final human coronary code, presented in the form of a four-digit numeric record. The belonging of this code to one of the coronary groups is determined by comparative analysis of the four-digit numerical records of the coronary codes. The coronary status of a person is established based on the person's belonging to a specific coronary group. Further, treatment and prophylactic measures are carried out taking into account the revealed coronary status, followed by determination at specified intervals of its change with the appointment of treatment and prophylactic measures corresponding to the newly identified coronary status of a person. Data on the revealed coronary status and the prescribed treatment and prophylactic measures are recorded on an electronic medium, which is a means of nosological identification of a person and an access key to a global information network, preferably the Internet, through which the doctor-patient automated interaction is carried out with the latter receiving the results of the study, a treatment plan -diagnostic measures and programs of prevention and / or treatment.

et al. Management of vascular risk factors in patients older than 80. // Med Clin (Barc). 2014 Aug 4;143(3):134.el-l 1. doi: 10.1016/j.medcli.2014.04.001. Epub 2014 Jun 5).In this known solution, we are talking about a variety of RFs, and the therapeutic and prophylactic effect is assumed on all RFs, which, perhaps, is not rational, since it takes a lot of time and requires significant funds, without highlighting priorities, and reduces the patient's motivation. At the same time, for the result of preventive intervention, it is optimal to identify a combination of individual most important causal RFs, which for a particular patient have the greatest contribution to his total risk of OCCS, with the construction of a personal profile of risk factors for a particular patient. Thus, it is known that a number of CVD RFs are non-modifiable (such as age, sex, heredity), while other RFs can be modified with the use of therapeutic and prophylactic measures with a decrease in the contribution of each to the patient's total CVD risk (smoking, cholesterol level, hypodynamia, etc.) (see, for example, Mitrofanov I.M. Presentation "Integral indicators of the risk of chronic non-inflammatory diseases (CHNID): methods used and possible approaches, FGBU" NTSKEM "SB RAMS, 07.06.2013, [Electronic resource ]: http://conf.nsc.ru/files/conferences/ictm-2013/presentation/168009/168010/2013-06-07_MitrophanovIM.pdf; Ricardo

et al. Management of vascular risk factors in patients older than 80. // Med Clin (Barc). 2014 Aug 4; 143 (3): 134.el-l 1.doi: 10.1016 / j.medcli.2014.04.001. Epub 2014 Jun 5).

Well-known scales and models make it possible to determine the total cardiovascular risk. The Framingham Study (DR Cox et al. Analysis of survival Data, London: Chapman and Hall, 1984: 175 p .; Cox DR Regression models and life tables (with Discussion). // Journal of the Royal Statisical Society, Series B, 1972, 34, 187-220). The total risk assessment based on the Framingham cohort is widely used in the clinic when choosing a treatment algorithm to identify patients with different degrees of risk. There are publications on the results of using the data obtained in this case, corresponding to the real ones in the studied region (Anderson K.M. et al. An updated coronary risk profile. A statement for health professionals. // Circulation. 1991, 83: 356-62).

At the same time, the authors of the Framingham cohort-based risk scale noted that the data obtained should be extrapolated with caution to other populations. At the moment, there are many publications that indicate that when using the data of the Framingham Risk Scale, for example, in the European Region, the risk prediction differs from the actually observed absolute risk. In this case, the absolute risk turns out to be overestimated. This is most clearly observed in the Mediterranean countries, as well as in the Central European region (Hense HW et al. Framingham risk function overestimates risk of coronary heart disease in men and women from Germany - results from MONICA Augsburg and the PROCAM cohorts. // Eur Heart J 2003, 3: 1-9. Marrugat J. et al. An adaptation of the Framingham coronary heart disease risk function to European Mediterranean areas. // J Epidemiol Comm Health. 2003; 57: 634-8. Menotti A. Et al. . Comparison of the Framingham risk function-based coronary chart with risk function from an Italian population study. // Eur Heart J. 2000.21: 365-70).

In 2003, a group of experts from the European and other communities of cardiology presented the SCORE (Systematic Coronary Risk Evaluation) scale, which was developed based on data from European population studies. At the same time, options were obtained for countries with low and high mortality rates from CVD (Conroy RM et al. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. // Eur Heart J. 2003, 24: 987- 1003). The SCORE scale is designed to assess the risk of death from CVD over the next 10 years in people 40 and older. To assess the risk on this scale, you need to know 4 indicators: smoking status, total cholesterol, age and SBP. Men have a higher cardiovascular risk than women. But after 65 years, the risks are almost equalized.

In 2019, with the release of the new European clinical guidelines for atherosclerosis, the SCORE scale was revised and updated. There are two variations on the 10-year risk of death from CVD (SCORE) scale:

- For a population of low risk of mortality (Low Risk), which includes countries: Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Malta, Portugal, Spain , Sweden, Switzerland, UK.

- For the High Risk population, which includes the countries: Albania, Armenia, Algeria, Bosnia and Herzegovina, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lebanon, Libya, Lithuania, Montenegro, Morocco, Poland, Romania, Serbia, Slovakia, Tunisia and Turkey.

Other countries with more than 350 CVD mortality per 100,000 population have an even greater risk, and the SCORE score for high risk may even underestimate it. These countries include the Russian Federation, as well as: Azerbaijan, Belarus, Bulgaria, Egypt, Georgia, Kazakhstan, Kyrgyzstan, Macedonia, the Republic of Moldova, Syria, Tajikistan, Turkmenistan, Ukraine and Uzbekistan.

Thus, in the Russian Federation, as in a number of other countries from the above list, the population has a very high risk of death from CVD in the next 10 years. However, a separate table for them has not been developed, therefore, the use of the SCORE system is carried out on a scale for high risk regions (High Risk), which reduces the forecast accuracy for Russia. To calculate the risk on the SCORE scale, select a column in the appropriate table depending on gender, age and smoking status, then determine the cell that most closely matches the SBP level and total cholesterol level. The cells indicate the risk in percent, depending on the indicators mentioned, by which the cardiovascular risk is calculated. Explanation of the results of the SCORE scale in%:

<1% - low,

≥1 to 5% - moderate,

≥5 to 10% - high,

≥10% is very high.

The SCORE scale is not suitable for those who already have CVD: coronary artery disease, heart attacks, strokes, as well as diabetes mellitus with target organ damage, chronic kidney disease with a glomerular filtration rate (GFR) less than 30 ml / min / 1.73 m2, as such individuals already have a very high risk of dying from CVD.

Considering the above, the assessment of the total risk using SCORE should be adapted to national conditions, resources, traditions and priorities, since it takes into account the heterogeneity of CVD and mortality in different European populations. However, the SCORE scale can be taken as a basis, as a model for the necessary adaptation of a more accurate forecasting of CVD risk, taking into account certain regional and national conditions.

The peculiarity of the SCORE model is that the risk is expressed by calculating both the absolute and the relative probability (absolute and relative risk - AR and RR) of the development of a fatal cardiovascular event in the next 10 years (European guidelines on cardiovascular disease prevention in clinical practice. joint Task Force of European and other societies on cardiovascular disease prevention in clinical practice. // Eur Heart J. 2003, 24: 1601-19). However, this scale does not provide the patient with an understanding of which risk factors are of the highest priority for him in terms of the choice of targeted therapeutic and prophylactic measures.

The model for assessing the total risk based on SCORE, built for the population of Russia, is based on an extensive database of prospective Russian studies that provided a level of evidence of 2A (Shalnova S.A., Oganov R.G., Deev A.D. -vascular diseases in the population of Russia. // Cardiovascular therapy and prevention, 2004, 3 (4), 4-11). This model predicts the likelihood of the risk of fatal OSCC within the next 10 years using the same set of features (RF) as the European SCORE scale - gender, age, smoking status, systolic blood pressure (SBP), total cholesterol. However, a distinctive feature of the Russian scale is the inclusion in the list of predicting RFs of the level of education and such causal RFs as: relative body weight, heart rate, high-density lipoprotein cholesterol (HDL-C). On the Russian scale, as well as on the European scale, the threshold for a high risk of fatal events is defined as exceeding 5% over ten years.

The limitation of the listed known risk scales is that the prediction of individual risk is extrapolated from the results of cohort observations. This cannot ensure the absolute accuracy of the result, but only determines its probabilistic nature - at the population level, and not for a specific person. In this case, the probability of coincidences with a small set of features included in the risk scales of the SCORE model (European and Russian) may not be high for specific individuals.

In 2007, a description was published for the patent of the Russian Federation No. 2352258 C2 (28.04.2007, State Research Institute of Preventive Medicine, Research Institute of Normal Physiology named after P.K. Anokhin, united with the one-profile department of the Moscow Medical Academy named after I.M. health "). The authors proposed an accurate assessment of the risk of developing CVD (absolute and relative - without regard to age - risk) using a list of RFs specific to the Russian population, with an expansion of indications for the use of the risk prediction method in comparison with previously known scales.

Previously, extensive cohort studies were carried out within the framework of a typical screening for CVD within the framework of the Soviet-American cooperation on an expanded program of lipid clinics (LC), according to a strictly standardized protocol, with preliminary training of personnel in epidemiological examination methods. In total, 7815 men and 5759 women were examined. The research is widely presented in publications.

Three consecutive screening surveys were also carried out within the framework of the WHO international program Monica (Monitoring trends and determinants of CVD) in 1984-86, 1988-88. and 1992-94

Prospective observation of the mortality of the examined cohorts was carried out according to the protocols of the LK and Monika cooperative programs. Based on the survey data, the time of prospective observation and the ranking of the causes of death, the modeling described above was carried out.

The well-known scale for assessing the total risk under the patent RU No. 2352258, based on the SCORE scale, allows predicting AR and AR CVD for patients 35-65 years old, having a level of evidence of 2A (Cardiovascular prevention 2017. Russian national recommendations. // Russian Journal of Cardiology. 2018, No. 6, p. 12; Oganov R.G., Shalnova S.A., Kalinina A.M. et al. "A new method for assessing the individual cardiovascular total risk for the population of Russia." Cardiology 2008; 48 (5): 87-91). At the same time, the absolute risk (AR) in the presence of CVD risk factors increases with age, and for young patients - up to 35 years old - it is very low, and therefore it is difficult to calculate it using a known scale. Therefore, for such young patients with low AR, the relative risk (ie, risk without regard to age) is of much greater interest. In the presence of CVD RF in a young group of the population (up to 35 years old), which, however, are underestimated, are clinically unnoticeable, but gradually over time exert their negative impact on a person's health as they grow older and older, further realizing themselves with various CVDs, taking years away healthy life, the definition of the profile of individual RF CVD is very important.

The essence of the known method according to the patent RU No. 2352258 was to assess the total risk of developing fatal CVD outcomes using the results of the mentioned cohort studies based on RF specific (characteristic) for the Russian population, which was established in the process of the mentioned high quality cohort studies (for example, the contribution of the level patient education). This was applicable to the general population and also to individuals without clinical evidence of CVD at the time of the study. A proportional risk regression model was constructed, in which a wide range of individual characteristics of a particular patient were included as variables, including not only variables used in known risk models (age, sex, SBP, total cholesterol level, smoking status), but also new ones, allowing to improve the accuracy of prediction and expand the indications for the use of the risk scale (heart rate, high-density lipoprotein cholesterol (HDL) level, body mass index (BMI), the status of exertional angina and pain typical of myocardial infarction, an assessment of ECG at rest, coded according to Minnesota code, alcohol use status). The absolute risk (AR) of CVD was calculated as:

Ri (T, x) -1-Si (T, x) = 1-Si (T, xr) ** exp (b * (x-xr),

where Ri (T, x) is the absolute (total individual) CVD risk for an individual with a "profile" x at time T for educational stratum i;

Si (T, x) is the corresponding survival function for an individual with a "profile" x for educational stratum i, assessed from the data;

xr - "profile" of a typical (average, reference) individual;

b is a vector of regression coefficients, estimated from the data and independent of the level of education.

The b * x value is called the risk profile of the patient with the x factors, and the b * (x-xr) value is called the relative profile (in relation to the "typical" individual xr).

The magnitude of the risk calculated according to this well-known method of assessing the total risk of CVD, which is typical for the Russian population, makes it possible to estimate the magnitude of the relative risk (RR), since it establishes a monotonous numerical scale, low values of which indicate low RR values. Values close to the values of the "typical" individual indicate the "typical" of the individual in terms of RR (for a given age), and high values of the scale indicate a high RR risk of an individual.

The above-mentioned studies led to the creation of an expert system (Shalnova S.A. et al. Russian expert system ORISCON - Risk Assessment of Major Non-communicable Diseases. // Cardiovascular Therapy and Prevention, 2013; 12 (4): 51-55). The ORISCON expert system (ES) was developed on the basis of the results of a 20-year prospective observation of large contingents of the population, representative for our country, and allows not only to determine the absolute and relative individual aggregate risk of major chronic non-communicable diseases (NCDs) in the next 10 years, but and highlight the categories of people at high risk, in whom the preventive effect can provide the maximum medico-social effect and form targeted basic recommendations on the tactics of managing this risk. The list of health parameters and factors included in the risk calculation model, as well as methods for their assessment were selected and formed on the principles of evidence-based medicine and are based on standard measurement methods recommended by WHO experts. ES is not diagnostic, it is intended to determine the cumulative risk of CHDI and can be used both independently and in integration with a comprehensive examination during clinical examination, preventive examinations, at the stage of pre-medical screening. The developed scale for assessing the total risk makes it possible to assess and predict the individual total 10-year risk of death from CVD in the Russian population, taking into account gender, age, smoking, SBP, total cholesterol (TC) levels, and education level, as well as to determine medical treatment and prophylactic tactics in real clinical practice (Shalnova S.A., Oganov R.G., Deev A.D. Assessment and management of the risk of cardiovascular diseases for the population of Russia.

Cardiovascular therapy and prevention. 2004; 3 (4): 4-11). Expanding the list of characteristics included in the model for calculating the total cardiovascular risk (CVR) is aimed at improving the accuracy of assessing individual risk, which was previously used in the domestic system "CardioRisk Expert" (Oganov R.G., Shalnova S.A., Kalinina AM et al. A new method for assessing the individual cardiovascular total risk for the population of Russia. Cardiology 2008; 48 (5): 87-91). The total CVD risk profile, determined by this system, includes general population RF, the influence of which on the risk of death from CHNIZ is assessed with a higher accuracy and reliability than by the previously known assessment systems. The main parameters included in the risk assessment were:

- age,

- floor,

- the level of education,

-SAD level,

- the level of diastolic blood pressure (DBP),

- heart rate (HR),

- the level of total cholesterol (TC),

- triglyceride (TG) level

- MT index (BMI),

- the presence of pain in the chest during exertion - the likelihood of exertional angina according to the standard WHO questionnaire,

- a history of myocardial infarction (MI),

- a history of cerebral stroke (MI),

- diabetes mellitus (DM) - standard questionnaire / history / fasting hyperglycemia,

- smoking,

- alcohol consumption.

Additional parameters registered in the ORISCON ES, not included in the risk assessment, but taken into account when forming individual recommendations, are:

- Personal history (cancer).

- Family history (hereditary history of CVD).

- Availability of antihypertensive therapy (AHT) at the time of examination.

- The likelihood of chronic obstructive pulmonary disease (COPD).

- Glucose level.

- Stress level.

- The level of physical activity.

- Poor nutrition (lack of consumption of vegetables and fruits).

However, the results of such studies demonstrate for a particular patient only his individual total risk in relation to CVD and an excess of the risk in comparison with the “typical” one for the Russian population. At the same time, these results do not make it possible to assess which RFs are available to the patient, or which personal combinations thereof are the most dangerous for him, in fact, the main causative factors that make the greatest contribution to the patient's total CVD risk (according to the patent 2352258), i.e. the most influencing on the possibility of developing an OCCS in a patient in the coming years in the structure of a given, established individual total risk at the time of the examination.

Thus, the continuation of research in this direction was gradually focused on the individual characteristics of the patient's RF, their combination and, accordingly, on the development of targeted individual therapeutic and prophylactic recommendations for a particular patient. The choice of this direction of research is explained by the absence of linear relationships in a living organism. Thus, the presence of any RF in a person with high absolute values (for example, high SBP or BMI values) that fall outside the range "typical" for his population does not mean that this is the most important, main causal risk factor, contributing to the total this patient's risk is the greatest contributor. Everything is much more complicated. Therefore, with all the set of RFs identified in a patient, it is more rational and effective to carry out therapeutic and prophylactic measures not immediately for all CVD RFs identified in the patient, but for the most significant ones that make the greatest contribution to the development of the disease in a given individual and which have the greatest contribution to its level. individual RR at the time of the survey.

Thus, in comparison with the analogue method: Oganov R.G., Shalnova S.A., Kalinina A.M. et al. "A new method for assessing the individual cardiovascular total risk for the population of Russia." Cardiology 2008; 48 (5): 87-91, we solved the problem of developing a method for determining at the time of examination in a particular patient-resident of Russia of working age (including persons under 35 years old) the most significant for him individual profile of modifiable causal factors of the total risk of CVD and CVD, which in the future, in the coming years, they can lead to the development of not only OSSS, but also death. The method provides the possibility of developing individual recommendations for the prevention of CVD and CVD associated directly with the selected modifiable RF and their combinations, with the determination of the individual (personal) profile of the factors of the total cardiovascular risk of a particular patient.

EFFECT: individualization of the main causal risk factors for CVD in a particular patient, which distinguishes this method from the known method for determining the total risk for a particular patient of the Russian population - above or below the average population. Based on the contribution of the patient's specific risk factors to his total risk, taking into account the population weighting coefficients for each factor, at the time of the examination, we identify the main causal factors of his individual total risk of OCCS, which in the next 10 years can likely lead to the development of fatal or non-fatal OCCS. Identification of the personal contribution of these factors or their combination to the individual total profile of the risk factors for OSCC in a given patient is necessary for a targeted therapeutic and prophylactic effect and modification of these particular RFs. This approach is especially important for younger patients (less than 35 years old) in whom RF is present, but compensated for by young age and may not be clinically manifested. Thus, the results of the proposed method make it possible to limit the feeling of false safety in such young patients who, due to their age, have a low absolute risk, but already have a history of causal factors for the realization of the risk of CVD in the future. The ranking of the identified CVD RFs and the determination of the profile of the personal total CVD risk orients the patients to pay the most attention to the individual causative RFs, and not to all known ones, which are available, which motivates the patient to follow the medical recommendations to the greatest extent. The identified CVD risk factors with age (after 35 years) without their preventive modification lead to an increase in the absolute risk of CVD in such patients and its realization in the next 10-year period, including with a fatal outcome.

To achieve this technical result, we propose a method for determining the individual profile of the factors of the total cardiovascular risk in a patient of the Russian population of working age, in which:

- conduct anamnestic, clinical, instrumental and laboratory examinations of the patient in order to identify the values of the following causal risk factors (RF) of cardiovascular diseases (CVD):

- systolic blood pressure (SBP) at rest, in mm Hg: less than 140 - 0 points, from 140 to less than 160 - 1 point, from 160 to less than 180 - 2 points, 180 and more - 3 points; moreover, if the patient has this SBP while taking antihypertensive drugs, 1 point is added to the SBP value in points;

- heart rate (HR) at rest, in beats / min: less than 80 - 0 points, from 80 to 84 - 1 point, from 85 to 89 - 2 points, 90 and more - 3 points; moreover, if the patient has a given heart rate while taking beta-blockers, 1 point is added to the heart rate in points;

- body mass index (BMI), in g / cm ² , ranked into groups: from 1.8 to less than 2.5; from 2.5 to less than 3.0; from 3.0 to less than 3.4; from 3.4 to less than 3.8; 3.8 or more;

- the status of exertional angina: yes - 1 point, no - 0 points;

- a history of acute myocardial infarction (AMI): no - 0 points, yes - 1 point,

- Acute stroke (CVA) in history: no - 0 points; yes - 1 point;

- dubious ECG signs of coronary heart disease (IHD): no - O points, yes - 1 point,

reliably established ECG signs of coronary artery disease: no - 0 points, yes - 1 point;

- smoking status for men:

non-smoker - smoked in the past, quit and does not smoke now: no - 0 points, yes - 1 point,

low-smoking - smokes less than 15 cigarettes per day: no - 0 points, yes - 1 point,

moderately smoker - smokes 15 to 20 cigarettes per day: no - 0 points, yes - 1 point,

heavy smoker - smokes more than 20 cigarettes per day: no - 0 points, yes - 1 point;

for women:

non-smoker - smoked in the past, quit and does not smoke now: no - 0 points, yes - 1 point,

low-smoking - smokes less than 6 cigarettes per day: no - 0 points, yes - 1 point,

moderately smoking - smokes from 6 to 10 cigarettes per day: no - 0 points, yes - 1 point,

smoking intensively - smokes more than 10 cigarettes per day: no - 0 points, yes - 1 point;

- alcohol consumption status: for men and women:

does not drink alcohol or drinks in small doses - 1 point,

uses medium and high doses - 2 points,

at the same time, 12 g of pure ethanol is taken as a standard dose,

small doses are considered: for men - no more than 2 doses per day, for women - no more than 1 dose per day,

average doses are considered: for men - 3 doses per day, for women - 2 doses per day,

high doses are considered to be the use of alcohol in doses above average per day;

- the level of low density lipoproteins (LDL), in mmol / l: less than 3-0 points, from 3 to less than 3.5 - 1 point, from 3.5 to less than 5 - 2 points, 5 or more - 3 points; moreover, if the patient has a given level of LDL while taking drugs that lower the level of LDL, 1 point is added to the value of the LDL level in points;

then the individual profile of the patient's total CVD risk factors at the time of examination is calculated, for which the value of each RF obtained in this way is multiplied by the corresponding weight coefficient from Table 1, and the resulting products are summed up to obtain the value of the individual profile of the patient's total cardiovascular risk factors.

Additionally, the presence of a confirmed diagnosis of diabetes mellitus is detected in the patient, or, in his absence, clinical and instrumental and laboratory studies are carried out to determine whether it is in the patient.

Then, taking the value of the individual total profile of the patient's risk factors as 100%, determine the share in it - the contribution in% of each of the obtained products of the individual RF values by their weight coefficients, thus determining the personal profile of the causative factors of the cardiovascular risk of the patient at the time of examination , where RFs with the highest values in% are referred to the main individual causative RFs of CVD, and in the case of a patient with diabetes mellitus, it is also referred to as the main individual causative RFs of this patient - requiring priority preventive or therapeutic measures to reduce the level of individual total cardiovascular risk , in accordance with the significance of the identified causal RFs in the individual patient profile.

Based on the foregoing, the proposed invention makes it possible to accurately determine (at the time of examination) the main causal RF in the structure of the individual total risk profile of CVD and OSSD in the next 10 years in a patient of working age (including those under 35 years old), - factors that make the greatest contribution to the possibility of realizing personal cardiovascular risk. Directional modification of such FDs leads to a decrease in the level of this risk (see below examples of the implementation of the method). Accordingly, this approach helps to reduce the percentage of mortality from CVD and disability from CVD in the population. At the same time, the corresponding profile of the main causal factors of his individual risk is determined for the patient - a list of his personal RFs, ranked (in%) in accordance with their contribution to his individual total risk. This makes it possible to choose a more targeted and effective therapeutic and prophylactic effect for modifying, first of all, these RFs. This approach is most relevant for the most active group of patients - the age of 35 years, who may already have certain causal factors of individual CVD risk without obvious cardiovascular manifestations. For this group, it becomes possible to adapt the extrapolation of the results of determining the risks of cardiovascular diseases obtained in population studies. The most susceptible for preventive measures of CVD RF modification is also a group of individuals whose risk, in the SCORE grades, lies in the moderate risk range (2-4.9% for fatal events and 6-15% for non-fatal events). Persons with a lower risk of CVD (mainly young people), but with RF of CVD, drop out of the field of vision of specialists, later replenishing the army of patients with CVD. However, the method we propose helps such people to see in a timely manner the most dangerous CVD RFs for them and to be able to modify them in time (to specifically correct and reduce the negative effect) in the course of treatment and prophylactic measures.

These issues are of paramount social importance, since the identification of the aforementioned personal main causal RF of CVDs and their timely prevention or treatment allows, as a result, to reduce disability and morbidity from CVD, to prevent the transition of persons with low and moderate CVD risk to the gradation of higher risk and very high risk. acute cardiovascular events.

Implementation of the method

When a patient is admitted for examination, the doctor conducts a survey, including the above CVD RF (history of previous myocardial infarction and / or stroke, smoking status, alcohol consumption, diabetes mellitus) and a clinical examination, with the determination of BMI, SBP and heart rate at rest , and also prescribes the patient to carry out instrumental and laboratory studies (ECG, biochemical blood test on an empty stomach with subsequent determination of the LDL level, a set of studies that allow either to exclude or identify and confirm the diagnosis of diabetes mellitus in the patient, if there is no data on it). All subsequent calculations according to this method can be carried out both manually by a health worker and using acceptable software (software), for example, such as in the systems "CardioRisk Expert", "Expert Screening".

At the next visit of the patient, in the case of using a computer system, before starting testing, you should make sure that the program is working correctly. The program enters the patient's data, both passport data and the results of the research obtained during the examination. Further, using the program using the weighting factors of CVD RF (shown in Table 1), the individual total profile of the cardiovascular risk (ICPR) of the patient is calculated at the time of the examination; during further examinations, for example, after a year, the ratio of risk factors may change, for example, due to changes in the patient's lifestyle, therefore, the risk profile will also change. Such a calculation, regardless of age, allows in dynamics - with sequential modification of causal risk factors - to track how the individual total CVD risk profile of the patient changes compared to the initial one (see below for examples of the method implementation).

The program (or manually a health worker) determines the IDS by using an algorithm for calculating the products of clinical and biochemical values of RF by the corresponding weight coefficients, with subsequent summation. For persons under 35 years of age, the level of absolute risk is low. If the level of risk increases, the program visualizes it for the patient on the monitor screen, comparing it with the average population - higher or lower, highlighting in color from green to red - from low to very high level of cardiovascular risk (see Fig. 2-3).

The development of the method was based on the determination of the total risk profile according to patent No. 2352258 (see tables 1 and 2 of the descriptions to this patent), with the introduction of a number of changes in the complex of risk factors, based on our own further research and a new algorithm for constructing an individual profile of CV risk factors ... This made it possible to calculate the individual total profile of the patient's RF, indicating the contribution of individual causal RF to the total risk of a particular patient in the Russian population, with the calculation of the fatal risk.

For the purpose of determining the most significant RFs that have the greatest contribution to the realization of the individual total risk of OSCC in a particular patient, the level of low density lipoproteins (LDL) was included in the set of RFs determined, which is determined on the basis of the levels of total cholesterol, HDL and triglycerides during a biochemical blood test. , according to the Friedwald formula: LDL cholesterol (in mmol / l) = total cholesterol - HDL cholesterol - TG / 2.2 (see, for example: Eurasian Association of Cardiology. National Society for the Study of Atherosclerosis (NOA). Diagnosis and correction of lipid metabolism disorders for the prevention and treatment of atherosclerosis. M, 2020, pp. 8-9. [Electronic resource]: http://cardio-eur.asia/media/files/clinical_recommendations/Diagnosis_and_correction of_lipid metaboli sm_disorders__tor_the prevention and treatment ofatherosclerosis.pdf) In addition Moreover, at present, direct enzymatic methods for the isolation of LDL have been developed, suitable for clinical diagnostic laboratories (Mach F., Baigent C, Ca tapano A. L., et al. 2019 ESC / EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2019., see p. 130. DOI: 10.1093 / eurheartj / ehz455; https://pubmed.nchi.nlm.nih.gov/31504418/).

For the purposes of our invention, the RF complex did not take into account the HDL level as such (as was done in patent No. 2352258), since this type of lipoproteins is not directly related to the RF OCCS according to the results of a meta-analysis of randomized and cohort studies of recent years, but was previously used only to calculate the level LDL. The program's consideration of a number of other factors has also been modified for the convenience of the user. For example, with regard to the meaning of the status of alcohol consumption in the specialized scientific literature, the following terminology has been adopted, taking into account the WHO recommendations: persons who consume no more than 1 day / day (drink / day, doses / day) (14 g / day - for women) and no more than 2 days / day (28 g / day - for men) are classified as moderate, light, low-risk or responsible drinking ("moderate, light, low-risk or responsible drinking", respectively). Heavy drinking ("heavy drinking") consume> 1 day / day (14 g / day) for women and> 2 days / day (28 g / day) - for men. Binge drinkers consume> 4 (56 g / day) drinks for men and> 3 drinks (42 g / day) for women within 2 hours. Regular drinkers ("regular drinkers") - once a week or <3 days / week (42 g / week) (Poteshkina N.G. et al. Alcohol in the prevention of cardiovascular diseases: familiar and unknown. // Russian cardiological magazine. 2015. No. 6 (122), pp. 100-105. [Electronic resource]: https://cyberleninka.ru/article/n/alkogol-v-profilaktike-serdechno-sosudistyh-zabolevaniy-privychnoe-i-neizvestnoe / viewer).

For Russian conditions, we used the following scale of alcohol consumption status values, which demonstrates (taking into account the weighting factors, see Table 1) that both intensive alcohol consumption and the absence of alcohol consumption are significant for increasing the level of total risk:

does not drink alcohol or drinks in small doses - 1 point,

consumes in medium and high doses (the amount is determined by the WHO criteria) - 2 points.

In this case, 12 g of pure ethanol are taken for one standard dose.

Small doses are considered: for men - no more than 2 doses per day, for women - no more than 1 dose per day, average doses are considered: for men - 3 doses per day, for women - 2 doses per day, high doses - alcohol consumption in doses above average per day.

For calculations related to BMI, taking into account the generally accepted classification of increased weight and degrees of obesity (see Fig. 1), BMI, in g / cm2, were ranked into the following groups: from 1.8 to less than 2.5 (normal weight, weight coefficient was taken as 0.00); from 2.5 to less than 3.0; from 3.0 to less than 3.4; from 3.4 to less than 3.8; 3.8 and more (the weights for each rank are shown in Table 1).

At the same time, the individual contribution of individual RFs to the total risk of a particular patient was assessed by us without taking into account the effect on the total risk of such an unmodifiable (unchangeable) factor as age. For this factor, it is unambiguously accepted in the scientific community that the risk increases with age, and in men it is higher than in women (after 65 years, this difference is leveled). Similarly, the level of education, as was convincingly proved by the authors of the invention under the patent 2352258, in the Russian population also affects the total risk of CVD: the higher the level of education, the lower the risk. Thus, these FRs in the structure of the combination of individual risk factors are already taken into account directly in the process of determining the relative (RR) and absolute risk (AR) in accordance with the mathematical model of patent 2352258 and are not the subject of our proposed method.

In connection with the foregoing, Table 1 presented by us with the values of the RF weight coefficients does not contain information on the age and level of education, only the weight coefficients of risk factors are given separately for men and for women. The weights of CVD risk factors were established in the process of the mentioned 20-year cohort qualitative epidemiological study, on the basis of which patent 2352258 was obtained. At the same time, the values of a number of weight coefficients, taking into account the above-mentioned modification of the complex of risk factors and the degree of their manifestation in the Russian population , in the course of the research, were accordingly adjusted and extrapolated to younger people when determining the individual total profile of risk factors, taking into account the population correction in the form of weighting factors (according to patent 2352258) and the updated program that we use in clinical practice.

As for determining whether a patient has already established or newly diagnosed diabetes mellitus (DM), it should be noted that, according to the literature and research, its development in a patient always aggravates the risk of CVD. Thus, it was shown that the frequency of CVD in men with diabetes is 2-3 times higher, and in women 3-5 times higher than in persons without disease (Ametov A.S., Kurochkin I.O., Zubkov A.A. Diabetes mellitus and cardiovascular diseases. // Breast cancer No. 13 dated 06/18/2014, pp. 954. [Electronic resource]: https://www.rmj.ru/articles/mnenie_eksperta/sakharnyy-diabet-i-serdechno-sosudistye-zabolevaniya /).

the risk of developing acute myocardial infarction increases 2.4 times (Cardiovascular prevention 2017. Russian Society of Cardiology. National Society for Preventive Cardiology. Russian Society for the Prevention of Noncommunicable Diseases. M. 2017, pp. 96-97. [Electronic resource]: https: // www.cardioc.rui / spetsialistam / klmichcskie-rekomendatsii / 2017_kardiovaskProfil.pdf)

It was also shown that the increase in the risk of developing CVS (cardiovascular events) in people with diabetes was greater in women and young people, which is especially important to convey to such patients who have a generally low RR. At the same time, RR and AR are higher in persons with long-term diabetes and microvascular complications, including kidney disease or proteinuria. Higher in diabetes and the risks of cardiovascular mortality (2019. ESC / EASD Recommendations on Diabetes Mellitus, Prediabetes and Cardiovascular Diseases. 5.1. Diabetes Mellitus, Prediabetes and Cardiovascular Risk, pp. 113-114. [Electronic resource]: https: // scardio.ru/content/Guidelines/ESC/3839-12465-1-PB.pdf).

Therefore, it is proposed to consider diabetes, in the case of its presence or initial detection, as another main causal factor in the structure of the personal profile of the patient's OSSS risk factors, which can be modified by therapeutic and prophylactic measures in order to reduce the total risk of the patient.

The status of exertional angina is defined as "is" or "not", based on the patient's complaints - whether he has ever experienced pain characteristic of this condition, according to the survey on the highly sensitive Rose questionnaire recommended by WHO (Clinical guidelines. Stable coronary heart disease. 2020, p. 15, 113-114). With regard to the history of OCCS (AMI and / or ACVA), when ranking the obtained values of the factor, it should be borne in mind that a confirmed diagnosis can be considered if there are appropriate medical reports. In the absence of such, according to the patient, it should be considered that the diagnosis has not been confirmed.

When analyzing the ECG results, signs may also be detected that indicate the presence of ischemic disorders implicitly (for example, a smoothed T wave, or other nonspecific changes that may indicate both ischemia and other violations of the processes of myocardial repolarization). Moreover, at rest, without carrying out a test with physical activity, changes in the ECG (especially in young people) may not be registered at all. Therefore, in doubtful cases, it is desirable to conduct an ECG with appropriate functional tests for greater reliability of its results in terms of establishing signs of ischemia.

ECG signs of coronary heart disease (CHD) are assessed for each of the gradations: doubtful signs and reliable, as: no - 0 points, yes - 1 point. Each of the gradations: doubtful and reliable signs - have their own weighting factors (see table 1).

It should be noted that the analysis of the factors considered here, their ranking, as well as the subsequent construction of a personal profile of the patient's risk factors can be done manually. However, for convenience and speed, these stages are included in the operation of our software, which allows not only to enter the received patient data, to carry out appropriate calculations, but also to present the results to the patient visually for better perception and increase his motivation to correct his health (modification, correction of the most significant FR).

Using the software, the systems also visualize on the screen the contribution of individual RFs available to the patient, his individual total risk profile (ICPR), indicated above. These data are presented on the screen in the form of a color chart, in which, respectively, those RFs of the patient are highlighted in red, the value of which, taking into account their personal combination, is at the level of high and very high cardiovascular risk compared to the "typical" for the Russian population ( see Figure 2-3). Average population values of risk factors (f ₀ , for men and women over 35 years old) are given, for example, in tables 1 and 2 in the description for patent 2352258. They are included in our software (ExpertScreening program). In this case, the data entered into the system are taken into account, including the presence (establishment) or absence of diabetes mellitus in the patient.

The main causative factors, individual for each patient, are those that make, in percentage terms, the largest contribution to the patient's IDMD determined. In the table issued by the system, they are indicated in red and occupy more than two columns (see Fig. 2-3). Thus, at the output, the patient's ISPR OSSS is obtained at the time of examination, which probabilistically reflects the patient's risk in the next 10 years. The profile itself is a list of the patient's causal modifiable RFs in descending order of their significance (contribution) to his individual total risk profile.

Further, including with the help of the system, the doctor can offer a number of treatment and prophylactic recommendations that are formed directly on the basis of the patient's data. Recommendations can also be displayed as text and printed to the patient (Figure 4-6).

The method for calculating the total cardiovascular risk is based on the assessment of survival in the proportional risk regression model (D. Cox's model) described in patent No. 2352258. The parameters of the model were estimated on the basis of the sample separately by gender and taking into account the stratification by education. In the chosen Cox regression model, it was assumed that the intensity of cardiovascular complications hi, j (t, x) (deaths from CVD) in each educational stratum for a fixed field decomposes (factorizes) into the product of a function that depends only on time t by an exponential function type, depending only on risk factors x through the risk profile (linear combination of factors) of the subject βi'x:

hij (t, x) = * ij (t) * exp (* pi'x),

where i = 1,2 is the number of the cohort by sex (i = 1 - men, j = 2 - women).

j = 1, 2, 3 - number of the educational group (subcohorts) (j = 1 - low, j = 2 - secondary, j = 3 - high education),

λi j (t) is a function of time only (different for each gender and age),

βi is a vector of regression coefficients characterizing the contribution of factors to the risk profile βi'x (different for each gender).

A characteristic feature of the proportional risk model is the independence of the RR from time (age), namely, if x1 and x2 are risk factors of two subjects, then the relative risk

RR (x1, x2) = hi, j (t, x2) / hi j (t, x1) = exp (βi '(x2-x1))

depends only on the difference between the risk profiles βi '(x2-x1) and does not depend on either time (age) or education. In this case, a subject with a minimum or average profile for a given age can be declared a reference, in relation to which for a subject with a "current high" xR profile, prophylactic recommendations can be given to reduce his profile.

AR of a cardiovascular episode (or death) for a given time interval T for a subject with a level of x factors is obtained from the ratio:

ARi, j (T, x) = 1-Si, j (T, xR) exp (bi * (xr-x))

Parameters βI and functions Si j (t, xR) are estimated from the sample and tabulated.

Based on this method, an autonomous program "ExpertScreening" was created, which is currently undergoing clinical testing and allows one to assess the individual total risk profile (ICPR) of a particular subject, calculate its AR (for patients aged 35 years and older) and OR (as for individuals younger than 35 years old and older) and give substantiated individual recommendations for its reduction by targeted therapeutic and prophylactic interventions on modifiable causal RF in the structure of a personal profile in a convenient automatic mode. The probability of a non-fatal risk (the risk of a non-fatal CV event) can also be calculated - by multiplying the obtained value of the individual total risk for males - by 4, for women - by 3 (Clinical guidelines. 2019. ESC / EAS guidelines for the treatment of dyslipidemia : lipid modification to reduce cardiovascular risk. // Russian Journal of Cardiology. 2020. 25 (5). pp. 121-193, see p. 132, additional figure 1).

Below are clinical examples of the implementation of this method using our software.

Example 1. Patient D., male, 30 years old, BMI 2.53, LDL - 3.48 (1 point), heart rate 90 bpm (3 points), SBP 143 mm Hg. Art. (1 point), smokes on average about 20 cigarettes a day (moderately smoker), drinks alcohol in medium doses (2 points), signs of coronary heart disease on the ECG are doubtful - 1 point, clinical episodes of exertional angina (1 point), heart attacks / strokes are not was (0 points). There is no diabetes mellitus.

We get ISPR, taking into account the weight.coeff. = 2.53 * 0.020104 (BMI) + 1 * 0.170928 (LDL) + 3 * 0.009247 (HR) + 1 * 0.020743 (SBP) + 1 * 0.761195 (smoking) + 2 * 0.026183 (alcohol) + 1 * 0.443317 (doubtful coronary heart disease on ECG) + 1 * 0.27622 (exertional angina) +0 (heart attack / stroke) = 3.78

Further, for this patient, we find the percentage contribution of each of his RF to his ISPR] at the time of the examination:

BMI: 2.53 * 0.020104 * 100%: 3.78 = 1.34%

LDL: 1 * 0.170928 * 100%: 3.78 = 4.52%

Heart rate: 3 * 0.009247 * 100%: 3.78 = 0.73%

GARDEN: 1 * 0.020743 * 100%: 3.78 = 0.55%

Smoking: 3 * 0.761195 * 100%: 3.78 = 60.4%

Alcohol: 2 * 0.026183 * 100%: 3.78 = 1.39%

IHD on ECG: 1 * 0.443317 * 100%: 3.78 = 11.7%

Angina pectoris: 1 * 0.27622 * 100%: 3.78 = 7.3%

ОИМ / ОНМК: = 0%

Thus, the most dangerous factor for the patient is smoking (60.4%), despite the fact that the patient smokes moderately. This is followed by the descending manifestations of IHD on the ECG (11.7%), and despite the fact that this diagnosis is doubtful, this contribution of RF to the profile seems to be quite significant, requiring modification of this RF (through additional examination, taking appropriate medications, adequate physical loads); exertional angina (7.3%). Further in importance is the contribution to the level of risk of LDL (4.52%), which also requires attention, despite the young age of the patient. The following RFs practically do not contribute to the patient's individual risk: alcohol consumption (1.39%), a slight increase in BMI (1.34%), increased heart rate (0.73%) (although in absolute value the heart rate is quite high), increased SBP (0.55%). This list reflects the personal profile of risk factors for OCCS of a given patient, in the absence of diabetes mellitus.

In the follow-up of this patient, despite the structure of his personal risk profile and recommendations, the patient did not reduce the intensity of smoking, there was no control over the dynamics of the ECG, and did not take medications to improve the functions of the heart. When examined 2 years later, the profile of his personal risk (contribution of factors) in the same patient changed due to the fact that other factors, provoked by the lack of therapeutic and prophylactic intervention, came to the fore in the risk structure, and the ISPR ₂ increased by almost one:

ISPR ₂ = 2 * 0.042834 (increased BMI) + 2 * 0.170928 (increased LDL) + 3 * 0.009247 (HR) + 2 * 0.020743 (SBP) + 3 * 0.761195 (smoking ) + 2 * 0.026183 (alcohol) + 1 * 1.228828 (reliable IHD on ECG) + 1 * 0.27622 (exertional angina) +0 (heart attack / stroke) = 4.34

The percentage contribution of each RF to a given level of ISPR for ₂ patients:

BMI: 2 * 0.042834 * 100%: 4.34 = ~ 2% (increase in contribution)

LDL: 2 * 0.170928 * 100%: 4.34 = 7.9% (increase in contribution)

Heart rate: 3 * 0.009247 * 100%: 4.34 = 0.64% (increase in contribution)

GARDEN: 2 * 0.020743 * 100%: 4.34 = 0.96% (increase in contribution)

Smoking: 3 * 0.761195 * 100%: 4.34 = 16.8% (reduced contribution)

Alcohol: 2 * 0.026183 * 100%: 4.34 = 10.1% (increasing contribution)

IHD on ECG: 1 * 1.228828 * 100%: 4.34 = 28.3% (a sharp increase in the contribution)

Angina pectoris: 1 * 0.27622 * 100%: 4.34 = 6.36% (decrease in contribution)

ОИМ / ОНМК: = 0%

According to this individual risk profile, it can be seen how in the dynamics the most significant initially risk factor - smoking, which was ignored by this patient, led after 2 years to a sharp increase in the contribution of factors that are directly related to cardiovascular pathology: signs of coronary artery disease (during exercise tests , confirmed), an increase in the contribution of SBP and heart rate, despite the fact that their point ranks (and absolute values) did not fundamentally change. The effect of increased body weight and LDL levels also increased.

This profile motivated the patient to change his lifestyle. In dynamics, after 2 years in this patient after adjusting the lifestyle due to gradual cessation of smoking, initiation of treatment for coronary artery disease, weight loss and taking drugs that improve the lipid profile (normal values of +1 point were achieved) and antihypertensive (SBP below 140 against the background drugs +1 point), there is a significant decrease in ISPR (1.96) compared even with the initial, primary moment of the examination:

ISPR ₃ = 0 (BMI) + 1 * 0.170928 (LDL) + 2 * 0.009247 (HR) + 1 * 0.020743 (SBP) +0 (smoking) + 1 * 0.249257 (alcohol) +1 * 1.228828 (IHD on ECG) + 1 * 0.27622 (exertional angina) +0 (heart attack / stroke) = 1.96

Thus, such a successful decrease in the level of ISPR is associated with the leveling of the most significant risk factors for a given patient in his life. However, the percentage contribution of each RF to a given ISPR of a patient also changes, showing which CVD risk factor should be given treatment and prophylactic attention in the first place at a given moment.

BMI: 0%

LDL: 1 * 0.170928 * 100%: 1.96 = 8.7%

Heart rate: 2 * 0.009247 * 100%: 1.96 = 0.94%

GARDEN: 1 * 0.020743 * 100%: 1.96 = 1%

Smoking: 0%

Alcohol: 1 * 0.249257 * 100%: 1.96 = 12.7%

IHD on ECG: 1 * 1.228828 * 100%: 1.96 = 62.7%

Angina pectoris: 1 * 0.27622 * 100%: 1.96 = 14.1%

ОИМ / ОНМК: 0%.

It should be remembered that the data obtained on the structure of the risk profile for a particular patient does not reflect one or another probability of the occurrence of OCCS, fatal events in the future, for example, in the next 10 years for a given patient. The subject of this invention is not itself as such a probable prediction of events in terms of the risk level - this problem is solved in patent No. 2352258, comparing the patient's risk level (AR and RR) with the average population for his age, "typical" risk. The present invention provides the establishment of the very structure of the profile of this risk, its "filling" with the contributions of specific RF for a particular patient, taking into account both the absolute values of his personal risk factors and population corrections in the form of the corresponding weight coefficients for RF established in cohort studies.

Example 2. Patient J., female, 38 years old, suffers from type 1 diabetes mellitus since her youth, is compensated, the patient is taking insulin. BMI 3.4, LDL - increased: 3.4 mmol / L (1 point) on statins - 2 points. SBP 145 mm Hg (1 point) while taking antihypertensive drugs - 2 points, heart rate: 83-84 - 1 point, while taking beta-blockers - 2 points.

Smoking, no smoking - 0 points. Drinks alcohol in small doses - 1 point.

IHD on ECG - no, 0 points.

Exertional angina pectoris: no - 0 points.

History of heart attacks-strokes: there was a confirmed lacunar stroke a year ago - 1 point.

It should be emphasized that, according to research data, every fourth woman after a stroke in the next 5 years develops a second stroke, therefore, in this case, the personal profile of CVD RF and the achievement of target values for blood pressure, blood sugar, heart rate, and BMI are so important. In this patient, the definition of ISPR will motivate the control of the most important RF profile for her, stabilizing the course of diabetes mellitus (maintaining the target blood glucose values) - as one of the main factors affecting the increased risk of CVS.

We calculate ISPR ₁ = (BMI) 3.4 * 0.079711 + (LDL) 2 * 0.081512 + (SBP) 2 * 0.015337+ (HR) 2 * 0.019387 + (smoking) 0+ (alcohol small) 1 * 0.03958 + (IHD on ECG) 0+ (angina pectoris) 0+ (stroke) 1 * 0.5436 = 1.08

With regard to the percentage contribution to it of each of the ISPR factors of a patient with diabetes mellitus, it has the following structure:

BMI: 3.4 * 0.079711 * 100%: 1.08 = 25.1%

LDL: 2 * 0.081512 * 100%: 1.08 = 15.1%

Heart rate: 2 * 0.019387 * 100%: 1.08 = 3.6%

GARDEN: 2 * 0.015337 * 100%: 1.08 = 2.84%

Smoking: 0%

Alcohol: 1 * 0.03958 * 100%: 1.08 = 3.7%

IHD on ECG: 0%

Angina pectoris: 0%

OIM / ONMK: 1 * 0.5436 * 100%: 1.08 = 50.33%

Thus, the personal risk profile of OSSS in this patient is in descending order of RF causality: the presence of a microstroke in the anamnesis has the most significant contribution to ISPR (50.33%), BMI (25.1%), LDL level (15.1%), and despite taking drugs that improve the lipid profile, which obviously requires further modification. Despite the increased values of heart rate and systolic blood pressure, their contribution to ISPR is small, which is apparently due to compensation due to the intake of appropriate drugs. However, the influence of all these RFs is aggravated by the presence of diabetes mellitus, which should be modified in the first place.

In the follow-up of the patient for 10 years, diabetes mellitus remained compensated due to rational therapy and diet, BMI while taking drugs decreased and was recorded at the level of excess weight (the diagnosis of obesity was withdrawn). LDL and BMI also decreased due to the selection of adequate therapy. The patient continues to constantly take lipid-lowering, antihypertensive drugs, drugs aimed at improving cerebral circulation, strengthening the vascular wall. Within the follow-up period after the initial examination, there were no repeated OCCRs. Thus, in this patient, due to targeted prophylaxis on the most important RFs for her, it was possible to avoid the implementation of OCCS within 10 years of follow-up from the moment of the initial examination. With regard to the indicated significant RFs during the compensation of diabetes mellitus, the patient retains her ISPR level, OCCR was not observed, the distribution of the RF contribution remains approximately at the same level.

This example demonstrates the successful control of the most important RFs in this particular patient with diabetes mellitus and the possibility of secondary prevention of stroke.

Example 3.

Patient M., male, 32 years old. Suffers from high blood pressure. SBP at rest up to 150 mm Hg (1 point, since the patient is taking antihypertensive drugs - 2 points), heart rate - 90 beats / min (3 points). BMI is not increased (0 points), LDL is 3.62 mmol / L against the background of lipid-lowering drugs (3 points). Does not smoke, does not consume alcohol. There was no diabetes mellitus, no signs of coronary artery disease on the ECG and no exertional angina pectoris, no AMI / stroke. Notes frequent work-related stresses.

We calculate ISPR ₁ taking into account the weight coefficient = 0 (BMI) + 3 * 0.170928 (LDL) + 3 * 0.009247 (HR) + 2 * 0.020743 (SBP) +0 (smoking) +0 (alcohol ) +0 (IHD on ECG) +0 (exertional angina) + 0 (heart attack / stroke) = 0.58.

The low level of ISPR, in general, is associated only with the young age of this patient, however, the patient has significantly pronounced personal CVD risk factors. For the available RFs, the patient profile is as follows:

LDL: 3 * 0.170928 * 100%: 0.58 = 88.4%

Heart rate: 3 * 0.009247 * 100%: 0.58 = 4.8%

GARDEN: 2 * 0.020743 * 100%: 0.58 = 7.15%

From this patient profile, it follows that the main causal risk factor for OCCS in his case is the level of LDL, atherosclerosis, which gradually, with age, can aggravate other risk factors, therefore, first of all, therapeutic and prophylactic measures should be directed specifically at him. In this case, the main complaint of the patient is arterial hypertension, in this case it has clinical manifestations, dyslipidemia is asymptomatic, which leads to a decrease in the patient's assessment of the existing pathological effect of high cholesterol levels. The patient underwent corrective anti-lipidemic therapy.

Control after 8 months, the values of LDL and heart rate decreased by 1 point, SBP 140 mm Hg. Art. (1 point, but since against the background of antihypertensive drugs - 2 points):

ISPR ₂ = 0 (BMI) + 2 * 0.170928 (LDL) + 2 * 0.009247 (HR) + 2 * 0.020743 (SBP) +0 (smoking) +0 (alcohol) +0 (IHD on ECG ) +0 (exertional angina) + 0 (heart attack / stroke) = 0.4.

We see that there is a decrease in the level of ISPR in this patient due to correctly selected therapy that affects the main (for this patient) risk factor - the level of LDL. Patient profile:

LDL = 2 * 0.170928 * 100: 0.4 = 85.5%

HR = 2 * 0.009247 * 100: 0.4 = 4.6%

GARDEN = 2 * 0.020743 * 100: 0.4 = 10.4%

We see that the contribution of LDL decreases, however, while the contribution of SBP increases, albeit slightly. Therefore, simultaneously with the modification of the LDL level (obviously, as one of the main causal risk factors) with lipid-lowering drugs, it is advisable for the patient to carry out further correction of antihypertensive therapy, choosing the optimal drugs, assessing whether the patient's level of physical activity is sufficient, since sport affects the blood pressure level. Monitoring CVD RF shows the effectiveness of recommendations and treatment.

Thus, by determining the individual, personal profile of CVD risk factors for specific patients, even against the background of a low total CVD risk (for example, for a young age, up to 35 years), showing the contribution of each of the causal factors to the total CVD risk of a particular patient, patients are motivated to carrying out the necessary therapeutic and prophylactic measures aimed directly at the identified main causal risk factors (having the largest weight contribution to the individual total risk of OSCC at the time of the survey). Monitoring and defining the profile of CVD risk factors, using targeted therapy, can reduce and change the negative impact of the contribution of factors to the total risk, preventing the progression of pathological processes leading to OSS, mortality and the development of cardiovascular diseases at a young age, loss of healthy years of life and subsequent formation of significant socio-economic losses at the population level.

Claims (32)

A method for determining the individual profile of factors of total cardiovascular risk in a patient of the Russian population of working age, in which: - conduct anamnestic, clinical, instrumental and laboratory examinations of the patient in order to identify the values of the following causal risk factors (RF) of cardiovascular diseases (CVD): - systolic blood pressure (SBP) at rest, mm Hg. Art .: less than 140 - 0 points, from 140 to less than 160 - 1 point, from 160 to less than 180 - 2 points, 180 and more - 3 points; moreover, if the patient has this SBP while taking antihypertensive drugs, 1 point is added to the SBP value in points; - heart rate (HR) at rest, beats / min: less than 80 - 0 points, from 80 to 84 - 1 point, from 85 to 89 - 2 points, 90 and more - 3 points; moreover, if the patient has a given heart rate while taking beta-blockers, 1 point is added to the heart rate in points; - body mass index (BMI), g / cm ² , ranked into groups: from 1.8 to less than 2.5; from 2.5 to less than 3.0; from 3.0 to less than 3.4; from 3.4 to less than 3.8; 3.8 or more; - the status of exertional angina: yes - 1 point, no - 0 points; - a history of acute myocardial infarction (AMI): no - 0 points, yes - 1 point, - Acute stroke (CVA) in history: no - 0 points; yes - 1 point; - doubtful ECG signs of coronary heart disease (IHD): no - 0 points, yes - 1 point, reliably established ECG signs of coronary artery disease: no - 0 points, yes - 1 point; - smoking status for men: non-smoker - smoked in the past, quit and does not smoke now: no - 0 points, yes - 1 point, low-smoking - smokes less than 15 cigarettes per day: no - 0 points, yes - 1 point, moderately smoker - smokes 15 to 20 cigarettes per day: no - 0 points, yes - 1 point, heavy smoker - smokes more than 20 cigarettes per day: no - 0 points, yes - 1 point; for women: non-smoker - smoked in the past, quit and does not smoke now: no - 0 points, yes - 1 point, low-smoking - smokes less than 6 cigarettes per day: no - 0 points, yes - 1 point, moderately smoking - smokes from 6 to 10 cigarettes per day: no - 0 points, yes - 1 point, smoking intensively - smokes more than 10 cigarettes per day: no - 0 points, yes - 1 point; - alcohol consumption status: for men and women: does not drink alcohol or drinks in small doses - 1 point, uses medium and high doses - 2 points, at the same time, 12 g of pure ethanol is taken as a standard dose, small doses are considered: for men - no more than 2 doses per day, for women - no more than 1 dose per day, average doses are considered: for men - 3 doses per day, for women - 2 doses per day, high doses are considered to be the use of alcohol in doses above average per day; - the level of low density lipoproteins (LDL), mmol / l: less than 3 - 0 points, from 3 to less than 3.5 - 1 point, from 3.5 to less than 5 - 2 points, 5 or more - 3 points; moreover, if the patient has a given level of LDL while taking drugs that lower the level of LDL, 1 point is added to the value of the LDL level in points; then the individual profile of the patient's total CVD risk factors at the time of examination is calculated, for which the value of each RF obtained in this way is multiplied by the corresponding weight coefficient from Table 1 given in the description, and the resulting products are summed up, obtaining the value of the individual profile of the total cardiovascular risk factors patient, additionally, the presence of a confirmed diagnosis of diabetes mellitus is detected in the patient, or, in his absence, clinical and instrumental and laboratory studies are carried out to determine if it is found in the patient; then, taking the value of the individual total profile of the patient's risk factors as 100%, determine in it the share - the contribution in% of each of the obtained products of the individual RF values by their weight coefficients, thus determining the personal profile of the causative factors of the cardiovascular risk of the patient at the time of examination , where RFs with the highest values in% are referred to the main individual causative RFs of CVD, and in the case of a patient with diabetes mellitus, it is also referred to as the main individual causative RFs of a given patient - requiring priority preventive or therapeutic measures to reduce the level of individual total cardiovascular risk, in accordance with the significance of the identified causative RF in the individual patient profile.

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