KR20090041817A - Qtc prolongation decision support system - Google Patents

Abstract

A cardiovascular system abnormal reaction discrimination system for providing fundamental research data about cardiovascular abnormal reaction considering correlation with the other factor through an ECG(Electrocardiology) is provided to protect a patient by previously predicting sudden death. If the information of the patient is inputted, it shows up based on the date which a hospitalization period or an exogenous register of the patient. The information of patient altogether shows up on a next screen. If the research objects patient measured ECG, the result is shown on the prolongation screen. The prolongation discernment result is shown on the final picture. The inputted information of the patient is managed under the separate database. The update task of data through patient or the pseudo-star division is conducted.

Description

Cardiovascular Adverse Event Determination System {QTc prolongation Decision Support System}

The present invention relates to a QTc prolongation determination system for a clinical trial using a computer.

 One way to assess the likelihood of QT prolongation of drugs is to measure PR, QRS, QT and QTc using ECG (Electrocardiology). ECG measurement methods can take into account factors such as sex, age, high blood pressure and diabetes. In addition, QTc prolongation is more likely to occur with age and eventually causes blood pressure problems, increasing the risk of other diseases. In gender, women are more likely to develop CHD than men. It is growing, and the occurrence by gender is also different. Therefore, ECG (Electrocardiology) is also used as a method for evaluating this. ECG should consider factors such as sex, age, high blood pressure and diabetes. In addition, QTc prolongation is more likely to occur with age and eventually causes blood pressure problems, increasing the risk of other diseases. Therefore, all factors of the patient should be considered.

 The purpose of this study was to provide basic research data on cardiovascular adverse events in consideration of correlation with other factors through ECG measurement results, and to help the health management of patients with clinical trials.

Recently, in several countries, some medicines such as antimicrobial agents and antihistamines have been canceled or removed from the market due to problems such as ventricular arrhythmias, torsade de point and heart attacks.

 Drugs associated with QTc prolongation induce severe ventricular arrhythmias and torsade de pointes in severe cases.

  The present invention aims to protect patients and predict the sudden death due to cardiac seizures, ventricular arrhythmias, and torsde de pointes.

 The present invention has been made to solve the above-mentioned problems, it is possible to protect patients and predict the sudden death due to cardiac seizures, ventricular arrhythmias and torsde de pointes caused by QTc prolongation can be used in clinical research The purpose is to provide such information.

As described above, the present invention "QTc prolongation discrimination system for clinical trials" is a sudden occurrence of secondary heart abnormalities such as a heart attack in a hospital where a lot of EVENTs occur in the work of the medical staff and patients all the time. It is effective in preventing. It will also provide the basis for ongoing research by providing basic data for clinical research. By predicting patients' diseases in advance, they can contribute to the systematic health care sector of the socio-economic system based on the reduction of economic burden and the improvement of health.

It relates to a QTc prolongation determination system for clinical trials of the present invention for achieving the above-described object.

 If the doctor enters the doctor's personal information and the patient's information in the initial screen, the result is displayed based on the hospitalization period or the date of the outpatient record to be searched and the next button is activated to move to the next screen.

The next screen will display all the patient's information. Age (age), hospitalization period, height (cm), weight (kg), drinking status, smoking status, and gender information are displayed at the time of admission or outpatients.

If the study subject measured ECG (Electrocardiography), the results will be displayed on the QT prolongation screen. As a result, ECG measurement date and time, HR, PR, QRS, QT, QTc, P-R-T 1/2/3, main diagnosis name, under diagnosis name, surgery and treatment name appear.

The final screen shows the result of QTc prolongation determination. Patient number, sex, age, Body Mass Index (BMI), list of medications taken and doses, and QTc prolonation determination results (normal, delayed). The inputted patient's information is managed in a separate database to update the data by classifying patients or doctors.

 Each processing step automatically finds the results in the hospital OCS database after the user enters patient information. In addition, data not in the hospital OCS database can be found directly in the medical record. After that, if you click the Next button, you will be automatically moved through the steps to display the QTc prolongation results. Input errors can be corrected by going directly to the relevant fields with the mouse, and moving to the previous step is configured to go directly with the mouse click. Accumulated data through this system is managed in the automated processing stage, and various missing data or error data that can be generated are refined and inquired by quality control and preprocessing program.

QTc prolongation is classified by QTc: 500 or less QTc group and 500 or more QTc delay group based on ECG (Electrocardiology) measurement and sex, age, hypertension, diabetes, hepatitis and diagnosis. To determine.

Hereinafter, the present invention will be described in detail with reference to the accompanying drawings.

 Detailed descriptions of each knowledge database are presented in tables and figures.

 Tables 1 and 2 show QTc prolongation-induced disease names and ICD code names.

ischemic heart disaseI20-i25 Cerebrovascular disease I60 -69 F01 Vascular dementia F01.9 Vascular dementia, unspecified F02 * Dementia in other diseases classified elsewhere G46.8 * Other vascular syndromes of brain in cerebrovascular diseases (I60-I67 +) I63.3 Cerebral infarction due to thrombosis of cerebral arteries I63.4 Cerebral infarction due to embolism of cerebral arteries I66.9 Occlusion and stenosis of unspecified cerebral artery I67.2 Cerebral atherosclerosis I67.8 Other specified cerebrovascular diseases I67.9 Cerebrovascular disease, unspecified I69 Sequela disease I69.8 Sequelae of other and unspecified cerebrovascular diseases O99.4 Diseases of the circulatory system complicating pregnancy, childbirth and the puerperium Z86.7 Personal history of diseases of the circulatory system Rheumatic feverI00-I02, I05-I09 A01.0 Typhoid fever I00-I02 Acute rheumatic fever I00 Rheumatic fever without mention of hear t involvement I01 Rheumatic fever with heart involvement I01.0 Acute rheumatic pericarditis I01.8 Other acute rheumatic heart disease I01.9 Acute rheumatic heart disease, unspecified I02.0 Rheumatic chorea with heart involvement I02.9 Rheumatic chorea without heart involvement I05.9 Mitral valve disease, unspecified I06.9 Rheumatic aortic valve disease, unspecified I07.8 Other tricuspid valve diseases I08.0 Disorders of both mitral and aortic valves I08.8 Other multiple valve diseases I09.0 Rheumatic myocarditis I09.1 Rheumatic diseases of endocardium , valve unspecified I09.2 Chronic rheumatic pericarditis I09.8 Other specified rheumatic heart diseases I09.9 Rheumatic heart disease, unspecified J17.0 * Pneumonia in bacterial diseases classified elsewhere J17.8 * Pneumonia in other diseases classified elsewhere L54.0 * Erythema marginatum in acute rheumatic fever (I00 +) M02 Reactive arthropathies M05 Seropositive rheuma toid arthritis Myocarditis I40-43 A01.0 Typhoid fever A18.8 Tuberculosis of other specified organs A36.8 Other diphtheria A36.8 Other diphtheria A38 Scarlet fever A39.5 + Meningococcal heart disease A52.0 + Cardiovascular syphilis A54.8 Other gonococcal infections A54.8 Other gonococcal infections A75.0 Epidemic louse-borne typhus fever due to Rickettsia prowazekii A75.9 Typhus fever, unspecified B26.8 Mumps with other complications B26.8 Mumps with other complications B33.2 Viral carditis B57.0 + Acute Chagas' disease with heart involvement (I41.2 *, I98.1 *) B57.2 Chagas' disease (chronic) with heart involvement B57.2 Chagas' disease (chronic) with heart involvement B58.8 Toxoplasmosis with other organ involvement B58 .8 Toxoplasmosis with other organ involvement D86.8 Sarcoidosis of other and combined sites D86.8 Sarcoidosis of other and combined sites I01.2 Acute rheumatic myocarditis I02.0 Rheumatic chorea with heart involvement I09.0 Rheumatic myocarditis I11.9 Hypertensive heart disease without (congestive) heart failure I40 Acute myocarditis I40.0 Infective myocarditis I40.1 Isolated myocarditis I40.8 Other acute myocarditis I40.9 Acute myocarditis, unspecified I41 * Myocarditis in diseases classified elsewhere I41.0 * Myocarditis in bacterial diseases classified elsewhere I41.1 * Myocarditis in viral diseases classified elsewhere I41.2 * Myocarditis in other infectious and parasitic diseases classified elsewhere I41.8 * Myocarditis in other diseases classified elsewhere I51.4 Myocarditis , unspecified J09 Influenza due to identified avian influenza virus J10.8 Influenza with other manifestations, other influenza virus identified J10.8 Influenza with other manifestations, other influenza virus identified J11.8 Influenza with other manifestations, virus not identified J11.8 Influenza with other manifestations, virus not identified M05. 3+ Rheumatoid arthritis with involvement of other organs and systems MVP I34.1 hypothyroidism E02-03 hypokalemia E87.6 hypocalcemia E58 Dietary calcium deficiency E83.5 Disorders of calcium metabolism P71.0 Cow's milk hypocalcaemia in newborn P71.1 Other neonatal hypocalcaemia bradycardia I49 Other cardiac arrhythmias I49.5 Sick sinus syndrome O36.3 Maternal care for signs of fetal hypoxia O68.0 Labor and delivery complicated by fetal heart rate anomaly P20.9 Intrauterine hypoxia, unspecified P29.1 Neonatal cardiac dysrhythmia R00.1 Bradycardia, unspecified anorexia nervosa, starvation F50.0 Anorexia nervosa F50.1 Atypical anorexia nervosa F50.2 Bulimia nervosa F98.2 Feeding disorder of infancy and childhood R63.0 Anorexia congestive heart failure I09.8 Other specified rheumatic heart diseases I11.0 Hypertensive heart disease with (congestive) heart failure I11.9 Hypertensive heart disease without (congestive) heart failure I13.0 Hyperte nsive heart and renal disease with (congestive) heart failure I13.2 Hypertensive heart and renal disease with both (congestive) heart failure and renal failure I50.0 Congestive heart failure I50.9 Heart failure, unspecified P29.0 Neonatal cardiac failure high serum drug concentrations T88.6 Anaphylactic shock due to adverse effect of correct drug or medicament properly administered ion channel mutations / polymorphisms polymorphisms F23.0 Acute polymorphic psychotic disorder without symptoms of schizophrenia severe hypomagnesemia E83.4 Disorders of magnesium metabolism P71.2 Neonatal hypomagnesaemia atrial fibrillation I48 Atrial fibrillation and flutter heart failure A52.0 + Cardiovascular syphilis E05.9 Thyrotoxicosis, unspecified I09.8 Other specified rheumatic heart diseases I09.9 Rheumatic heart disease, unspecified I11.0 Hypertensive heart disease with (congestive) heart failure I11. 9 Hypertensive heart disease without (congestive) heart failure I13.0 Hypert ensive heart and renal disease with (congestive) heart failure I13.1 Hypertensive heart and renal disease with renal failure I13.2 Hypertensive heart and renal disease with both (congestive) heart failure and renal failure I24.8 Other forms of acute ischaemic heart disease I39.8 * Endocarditis, valve unspecified, in diseases classified elsewhere I43.8 * Cardiomyopathy in other diseases classified elsewhere I50 Heart failure I50.0 Congestive heart failure I50.1 Left ventricular failure I50.9 Heart failure, unspecified I51.5 Myocardial degeneration I52.0 * Other heart disorders in bacterial diseases classified elsewhere I97.1 Other functional disturbances following cardiac surgery I97.8 Other postprocedural disorders of circulatory system, not elsewhere classified J81 Pulmonary oedema O29.1 Cardiac complications of anaesthesia during pregnancy O74.2 Cardiac complications of anaesthesia during labor and delivery O75.4 Other complications of obstetric surgery and procedures O89.1 Card iac complications of anaesthesia during the puerperium P29.0 Neonatal cardiac failure R09.2 Respiratory arrest R54 Senility T81.8 Other complications of procedures, not elsewhere classified T86.2 Heart transplant failure and rejection T86.3 Heart-lung transplant failure and rejection Y62 .5 During heart catheterization Y62.6 During aspiration, puncture and other catheterization

Table 1 shows QTc prolongation-induced disease name and ICD code name. When determining QTc prolongation, people with the diseases shown in Table 1 are excluded when determining pure QTc prolongation.

ischemia F06.8 Other specified mental disorders due to brain damage and dysfunction and to physical disease G45.8 Other transient cerebral ischaemic attacks and related syndromes G45.9 Transient cerebral ischaemic attack, unspecified G95.1 Vascular myelopathies H34.2 Other retinal artery occlusions I24.8 Other forms of acute ischaemic heart disease I24.9 Acute ischaemic heart disease, unspecified I25.5 Ischaemic cardiomyopathy I25.6 Silent myocardial ischaemia I25.9 Chronic ischaemic heart disease, unspecified I67.2 Cerebral atherosclerosis I67.8 Other specified cerebrovascular diseases I99 Other and unspecified disorders of circulatory system K55.0 Acute vascular disorders of intestine K55.1 Chronic vascular disorders of intestine K55.9 Vascular disorder of intestine, unspecified M62.2 Ischaemic infarction of muscle N28.0 Ischaemia and infarction of kidney O99 .4 Diseases of the circulatory system complicating pregnancy, childbirt h and the puerperium P29.4 Transient myocardial ischaemia of newborn P91.0 Neonatal cerebral ischaemia T79.6 Traumatic ischaemia of muscle hypothyroidism E00 Congenital iodine-deficiency syndrome E00.9 Congenital iodine-deficiency syndrome, unspecified E01 Iodine-deficiency-related thyroid disorders and allied conditions E01 Iodine-deficiency-related thyroid disorders and allied conditions E01.8 Other iodine-deficiency-related thyroid disorders and allied conditions E02 Subclinical iodine-deficiency hypothyroidism E03 Other hypothyroidism E03 Other hypothyroidism E03.0 Congenital hypothyroidism with diffuse goitre E03. 1 Congenital hypothyroidism without goitre E03.2 Hypothyroidism due to medicaments and other exogenous substances E03.3 Postinfectious hypothyroidism E03.8 Other specified hypothyroidism E03.9 Hypothyroidism, unspecified E03.9 Hypothyroidism, unspecified E89.0 Postprocedural hypothyroidia F02.8 * De0 oth er specified diseases classified elsewhere G73.5 * Myopathy in endocrine diseases M14.5 * Arthropathies in other endocrine, nutritional and metabolic disorders P72 Other transitory neonatal endocrine disorders P72.2 Other transitory neonatal disorders of thyroid function, not elsewhere classified Q86 Congenital malformation syndromes due to known exogenous causes, not elsewhere classified

Table 2 shows QTc prolongation-induced disease name and ICD code name. When determining QTc prolongation, people with the diseases shown in Table 2 are excluded when determining pure QTc prolongation.

Generic name Class / Clinical Use Comments Amiodarone Anti-arrhythmic / abnormal heart rhythm Females> Males, TdP risk regarded as low Amiodarone Anti-arrhythmic / abnormal heart rhythm Females> Males, TdP risk regarded as low Arsenic trioxide Anti-cancer / Leukemia Bepridil Anti-anginal / heart pain Females> Males Chlororoquine Anti-malarial / malaria infection Chlorpromazine Anti-psychotic / Anti-emetic / schizophrenia / nausea Cisapride GI stimulant / heartburn Restricted availability; Females> Males. Clarithromycin Antibiotic / bacterial infection Disopyramide Anti-arrhythmic / abnormal heart rhythm Females> Males Dofetilide Anti-arrhythmic / abnormal heart rhythm Domperidone * Anti-nausea / nausea not available in the United States Droperidol Sedative; Anti-nausea / anesthesia adjunct, nausea Erythromycin Antibiotic; GI stimulant / bacterial infection; increase GI motility Females> Males Erythromycin Antibiotic; GI stimulant / bacterial infection; increase GI motility Females> Males Halofantrine Anti-malarial / malaria infection Females> Males Haloperidol Anti-psychotic / schizophrenia, agitation Ibutilide Anti-arrhythmic / abnormal heart rhythm Females> Males Levomethadyl Opiate agonist / pain control, narcotic dependence Mesoridazine Anti-psychotic / schizophrenia Methadone Opiate agonist / pain control, narcotic dependence Females> Males Methadone Opiate agonist / pain control, narcotic dependence Females> Males Pentamidine Anti-infective / pneumocystis pneumonia Females> Males Pentamidine Anti-infective / pneumocystis pneumonia Females> Males Pimozide Anti-psychotic / Tourette's tics Females> Males Procainamide Anti-arrhythmic / abnormal heart rhythm Procainamide Anti-arrhythmic / abnormal heart rhythm Quinidine Anti-arrhythmic / abnormal heart rhythm Females> Males Quinidine Anti-arrhythmic / abnormal heart rhythm Females> Males Sotalol Anti-arrhythmic / abnormal heart rhythm Females> Males Sparfloxacin Antibiotic / bacterial infection Thioridazine Anti-psychotic / schizophrenia

The information in Table 3 lists the drugs that are likely to cause QTc prolongation.

1 is a flow chart of the QTc prolongation determination system for clinical trials of the present invention,

FIG. 2 is a screen for input by a user (medical person) of FIG. 1,

3 is a screen in which patient information is diagnosed and examined through inpatient or outpatient classification, and shows a summary of ECG measurement results and patient personal information.

Figure 4 is a screen showing the ECG measurement data for diagnosis and QTc prolongation, diagnosis, surgical treatment name,

Figure 5 shows sex, age, smoking, drinking, ECG (HR, PR, QRS, QT, QTc, P-R-T 1,2,3), height, weight, diagnosis for determining QTc prolongation. Considering all possible factors, the results are found by looking for secondary QTc prolongation, not essential QTc prolongation.

Claims (3)

 As a QTc prolongation discrimination system for clinical trials, the QTc prolongatoin is considered in consideration of the characteristics of the patient to provide health care services that can improve the effect of improving the health of the patient.  It provides the basis for effective disease research by providing the basis for clinical research on the occurrence of problems due to sudden death due to secondary cardiac abnormalities.  Critical risk factors, such as information in the hospital OCS database and medical records, can be viewed in one place, and health care professionals can determine the quality of care. It is a system that can effectively manage patients with many diseases.

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