DE102019101122A1 - Mobile system for the exclusion of coronary heart disease and procedure for the provision of interim results - Google Patents

Abstract

The invention relates to a mobile system for the exclusion of a heart disease, its use, and a method for providing intermediate results which enable a heart disease to be excluded by a doctor.

Description

The invention relates to a mobile system for the exclusion of a coronary heart disease and / or a myocardial infarction, its use, and a method for providing intermediate results that enable the exclusion of a heart disease.

State of the art:

Various examination methods are known in the prior art, in particular to examine human patients for heart diseases. For the purposes of the invention, the term "heart disease" is preferably intended to mean diseases such as heart attack, myocardial infarction or coronary heart diseases, i.e. Diseases of the heart or near-heart vessels include, but are not limited to. It is a disadvantage of the examination methods known in the prior art that their implementation usually requires an inpatient hospital stay, since they are associated with a considerable risk for the person concerned. For example, so-called cardiac catheter examinations are often carried out, but for the most part remain without findings and in particular represent a significant invasive intervention for the patient. Here it would be desirable if those patients in whom a coronary disease, i.e. a relevant narrowing of the coronary arteries, even without a cardiac catheter, can be ruled out, which could save stress and the risk of invasive diagnostics.

On the other hand, there are too few mobile or outpatient electrocardiogram devices available in many areas to ensure adequate or desirable care for the population. As a result, patients who have suffered a heart attack or are living with delayed cardiac arrhythmias often have very late access to such ECG examinations, although in these cases a timely ECG derivation could have enabled improved care and therapy .

In other regions, an emergency medical service is required to perform an EKG examination, which often leads to an undesirable hospital stay for the patient. This is due in particular to the fact that often only individual types of examinations can be performed on an outpatient basis, but the results of these often do not lead to a comprehensive overall picture of the patient's health status. Even if different examinations have been carried out on one patient, the corresponding results are often not available to the attending doctor at the same time or are only insufficiently related to one another. In addition, the joint evaluation of examination results that were not collected at the same time can lead to falsified results in the diagnosis.

Cardiac catheters are used three times more frequently in Germany than in other countries. Scarce 1 This study is carried out millions of times a year in Germany. However, about 80% of these cases could be avoided if a safe, reliable and quick diagnosis of exclusion for coronary heart disease and myocardial infarction were available.

It is therefore an object of the present invention to provide a mobile system for the exclusion of a heart disease, in particular coronary heart diseases and myocardial infarctions, with which the disadvantages and deficiencies of the prior art are overcome. The system to be provided should make it possible, in particular, for the results of various examinations in the context of heart diseases to be combined with one another in order to be able to rule out the presence of coronary heart disease and / or myocardial infarction particularly effectively. The system should be mobile, i.e. it should also be able to be used at home or in an ambulance, especially without the presence of a doctor. The system to be provided should provide reliable information about the presence of coronary heart disease and / or myocardial infarction as quickly as possible and reduce the number of (unnecessary) hospital stays and cardiac catheter examinations.

It would also be desirable if the system to be provided were designed to be particularly space-saving and robust so that it could withstand everyday use.

Description of the invention:

The task is solved by the features of the independent claims. Advantageous embodiments of the invention are described in the dependent claims.

According to the invention, a mobile system for outpatient exclusion of coronary heart disease and a myocardial infarction is characterized in that the system comprises means for carrying out a 4-point 22-channel electrocardiogram, as well as means for carrying out ultrasensitive phonocardiography examinations and means for the immediate determination of hs troponin I .

The system according to the invention can be used to determine parameters which are made available as the basis for a conclusive evaluation by an evaluation body, for example a doctor. A reliable diagnosis of exclusion can be made, which in many cases prevents hospitalization of the patient.

The use of a 22-lead ECG with only four electrodes is advantageous because such a device enables the diagnosis of anterior, lateral and posterior heart attacks. With the 22 channels, diagnoses of the classic 12 leads can be significantly expanded. On the one hand, there is the possibility of significantly improving the diagnosis of myocardial infarction, since posterior wall infarctions and infarctions on the right heart can now be diagnosed safely. On the other hand, the localization of cardiac arrhythmias is also possible.

An ECG is essential to rule out an infarct. The ECG is particularly meaningful for the diagnosis of acute myocardial infarction if there is a transmural infarction. This is the case when a certain section of the ECG curve, the ST segment, is raised in an arc. This infarction is called ST-elevation infarction (STEMI infarction). Diagnosing an infarct is more difficult if the ST segment is not raised despite typical infarct pain. In such cases, the ECG can show persistent or rapidly changing ST segment reductions, but also inconspicuous or unspecific ECG findings. With such a non-ST elevation infarction (NSTEMI), further examinations must be carried out in order to make the diagnosis "heart attack". Although the system of the invention is primarily used for exclusion diagnosis, it can also be used for detection purposes.

In the sense of the invention, it is preferred that the means for carrying out ultrasensitive phonocardiography examinations are set up to determine flow noises of blood in vessels close to the heart, to convert them into frequency images and to compare them with reference frequency images. Such reference frequency images are formed in particular from those frequency images that were recorded in healthy or essentially healthy people. These reference frequency images can be stored in databases that the proposed system can access. However, the databases can also be part of the system. For example, they can be stored in an evaluation device that can be part of the system. The ultrasensitive phonocardiography examination works in a particularly high resolution range. For the purposes of the invention, the term “cardiac vessels” is preferably to be understood as cardiac vessels. The CADScore® device is particularly preferred. If a value of less than 20 is achieved with this device, a disease of the coronary arteries can be excluded with high certainty.

Hs (highly sensitive) troponin I is a protein complex that occurs, for example, in the human heart muscle and forms part of the moving part of the muscles. The presence of hs troponin I in the blood can indicate damage to the heart muscle. In coronary heart diseases, the hs troponin I value increases before an infarction, but is still usually in the normal range of less than 14 ng / l.

Values below 14 ng / l hs troponin I are to be classified as normal values. At values below 10 ng / l, particularly preferably below 5 ng / l, the probability of coronary heart disease is very low. These values also depend on the measuring devices currently in use and may therefore change somewhat in the future. In order to increase the security of the exclusion, the system of the invention additionally uses an ultrasensitive phonocardiography examination (e.g. with the CADScore® device). If this examination provides additional values of less than 20 (for CADScore®), the exclusion of coronary heart disease and a myocardial infarction is possible with almost 100% certainty.

It was completely surprising that the detection of particularly low hs troponin I values in combination with a 4 point 22-channel ECG examination and an ultrasensitive phonocardiography examination enables a particularly safe exclusion of coronary heart disease and / or a myocardial infarction.

The inventor has found that the use of the intermediate results, which result from the examination methods mentioned, which can be determined with the proposed system, leads to a synergistic effect in the sense that the diagnostic reliability of the preferably combined results evaluated intermediate results compared to conventional methods are known from the prior art, is significantly improved, and to an unexpected degree. The combination of the three examinations increases the safety, which is almost 100%. This result can be achieved within 15 minutes, which makes the invention stand out from the prior art.

It is particularly advantageous that all three examinations to be combined can be carried out as a point-of-care test. This creates an ultra mobility of the system that can be used practically anywhere.

It was also surprising that the proposed system can be particularly space-saving, compact and robust, which makes it particularly simple, e.g. can be carried in ambulances. Because of its small size and compactness, the proposed system can be manufactured particularly inexpensively. In this context, it is preferred that the system can be used in a completely mobile manner and, in particular, can use telemedicine methods to communicate with an evaluation center, which can be located at another location. In other words, the proposed system is set up to forward the individual examination results, which in particular represent intermediate results for later evaluation by an evaluation point, to this evaluation point, wherein this data transmission can take place, in particular, automatically or automatically when the tests are completed or when the intermediate results are determined were. In the sense of the invention it can be preferred that the intermediate results of the individual examinations are jointly transmitted to the evaluation point. However, it can also be preferred that the intermediate results are transmitted individually to the evaluation point.

When using the proposed system, the evaluation point has the particular advantage that the intermediate results or examination data were each determined with an identical set of system components, so that the evaluation point, i.e. e.g. the treating or diagnosing doctor can gain experience in evaluating the data determined by the system components. For the purposes of the invention, the term “system components” preferably includes the means for carrying out the 22-channel electrocardiogram, the means for carrying out the phonocardiography examination and the means for immediately determining the hs troponin I value. In particular, the interim results of the three examinations can be carried out essentially at the same time or within a short period of time, so that the evaluation body has a data set of interim results available for its conclusive evaluation, which represent or reflect a uniform state of health of the patient. It is very particularly preferred in the sense of the invention that the three examinations with the system components can be carried out essentially simultaneously, for example within 15 minutes.

It was completely surprising that, based on the interim results of the three examinations that can be carried out with the proposed system or its components, a significant improvement or increase in the reliability of the exclusion diagnosis for coronary heart diseases and / or myocardial infarctions can be achieved in a synergistic manner. Tests have shown that, for example, an almost 100% exclusion of myocardial infarctions and coronary diseases can be achieved in acute assessment. In addition, the proposed system enables a surprisingly accurate individual residual risk assessment, which has so far not been achievable, in particular with comparable accuracy, speed and mobility. In particular, the proposed system enables a particularly safe outpatient and / or mobile exclusion of myocardial infarctions and / or coronary heart diseases within only 15 minutes in people who suffer, for example, from suddenly occurring chest and / or heart pain.

It was particularly surprising that the interim results of the three examination methods (22-lead ECG, phonocardiography and hs troponin I determination) can be provided with the proposed system, and that no major expenditure on equipment is required. The invention thus turns away from the prior art, since experts had previously assumed that the reliable and exact provision of data required a high level of equipment, as can usually only be kept in hospitals. Since it is now also possible to provide reliable interim results with a mobile and relatively inexpensive system that can also be used without medical participation, the present invention can save considerable costs in the healthcare system.

The components of the system, ie the means for carrying out the 22-lead ECG, the ultrasensitive phonocardiography and the hs troponin I determination, can together form a device which is made available to a patient for home use. It can also be preferred that the examinations are carried out with individual devices. The determined intermediate results can be sent to the evaluation position using a smartphone or another mobile communication device, for example. It is preferred in the sense of the invention that the proposed system provides intermediate results, either at the same time, after their transmission or at a later point in time, preferably at a different location by a doctor or trained specialist personnel be evaluated to rule out coronary heart disease and / or myocardial infarction.

In the sense of the invention, it is particularly preferred that the mobile ECG system can be operated on an app basis and that the derived ECG data can be transmitted to a doctor or an evaluating body, preferably by means of telemedicine. It is preferred in the sense of the invention that the transmission of the data is essentially immediate, i.e. immediately after their derivation from the human body. The data or the intermediate results are preferably transmitted using suitable telemedicine means of communication.

The app-based nature of the means for performing a multi-channel electrocardiogram in the sense of the invention preferably means that the EKG data that were derived by means of the electrodes can be forwarded to a smartphone, for example. This forwarding can take place, for example, by wire or cable. It can also be preferred in the sense of the invention that wireless transmission methods are used, such as Bluetooth or WLAN. An app, and therefore a software program product, can be installed on the smartphone, wherein the software program product can be set up to store, display, evaluate or forward the determined ECG data, i.e. to be transmitted in particular to the evaluation unit. For example, the raw data can be forwarded or processed data, i.e. data that has been processed and / or evaluated, for example, within the app or within the smartphone. It may also be preferred to transmit screenshots of the display of the EKG data to the evaluation site, so that the diagnosing doctor can fall back on a graphic preparation and clear presentation of the intermediate results in his concluding evaluation of the intermediate results. In the sense of the invention, it is particularly preferred that the determined ECG data can be stored on the smartphone, preferably there being no connection between the storage of the data or intermediate results and the effect of the system or its components on the patient's body. In other words, the proposed method can include storing the ECG or other data or intermediate results without there being a connection between the storage of the data and the effect of the system on the patient's body. In the sense of the invention, it can also be preferred to use another mobile communication device instead of a smartphone, such as, for example, a conventional mobile phone, a Palm and / or a tablet PC, without being restricted thereto.

In the sense of the invention, it is also preferred that the means for immediate determination of the hs troponin I value comprise a mobile evaluation unit. A blood sample, for example comprising 2-3 blood drops, is filled into an examination container. The test container is preferably designed such that it can be inserted into the mobile evaluation unit so that the blood in the test container on site, i.e. in the mobile evaluation unit, examined or the results can be evaluated. It is preferred in the sense of the invention that the mobile evaluation unit comprises a display device on which the results of the blood test can be displayed. In the sense of the invention, it is also preferred that the means for immediate determination comprise communication means with which the results of the blood test can be transmitted to an evaluation point. In the sense of the invention, it is preferred that the immediate determination of the hs troponin I value is a point of care examination (PoC), which in the context of the present invention can be carried out in particular by the patient himself, for example at his home , and no medical supervision is needed.

In the context of the present invention, it is particularly preferred that a combination of an ultramobile 4-point 22-channel ECG, a PoC-hs troponin I examination and an ultrasensitive phonocardiography is carried out. By providing the interim results of the system components, the proposed system is advantageously set up to rule out the presence of coronary heart diseases and / or myocardial infarctions particularly safely and quickly in people with chest pain symptoms without an inpatient stay being necessary. The specific procedure is preferably based on the schematic representation of the corresponding method 1 forth.

In a further aspect, the invention relates to a method for providing intermediate results, the intermediate results making it possible for a doctor or trained specialist staff to rule out coronary heart disease and / or myocardial infarction. The proposed method is characterized in that the means for carrying out a 22-channel electrocardiogram, the means for carrying out ultrasensitive phonocardiography examinations and the means for immediate determination of the hs troponin I value are components of a proposed system for the exclusion of a heart disease and individual intermediate results deliver, which can be evaluated by an evaluation body, for example by a treating doctor. It is a significant advantage of the proposed method or the use of the proposed system that the method does not include any essential steps that have to be carried out under medical supervision - for example because they pose a risk to the patient.

In a further aspect, the invention relates to a use of the proposed mobile system to exclude coronary heart disease and / or a myocardial infarction. The use of the system consists in particular in that the system components can be used to determine intermediate results required for a final exclusion diagnosis by a patient himself, no doctor having to be present when determining the examination data. The diagnosis and conclusive evaluation are preferably carried out without the presence of the patient, for example in the practice of the treating doctor, who undertakes the evaluation of the data determined using the system or its components. In particular, the use of the proposed mobile system and the proposed method represent an essentially non-invasive method (with the exception of minimal blood sampling), which only comprises steps which do not have to be carried out by a doctor or technician and which in particular do not pose a significant risk to the Patients are connected. In other words, it is particularly preferred in the sense of the invention that the intermediate results are determined by the patient himself with the components of the mobile system without a doctor being present.

In the sense of the invention, it is preferred that the three examinations are carried out essentially simultaneously. In the context of the present invention, it is particularly preferred that the tests mentioned are carried out within, for example, 20 minutes, preferably 15 minutes. This enables a particularly quick diagnosis of exclusion, which was not previously possible in the prior art. A particular advantage of the essentially simultaneous determination of the intermediate results is that the results in this way represent an essentially identical state of health, stress or relaxation of the patient, so that an unadulterated and direct evaluation of the intermediate results is made possible by the doctor.

Further advantages, features and details of the invention can be gathered from the further subclaims and the description below. Features mentioned there can be essential to the invention individually or in any combination. Thus, the disclosure of the individual aspects of the invention can always be referred to mutually.

• 1 schematische Darstellung einer bevorzugten Ausführungsform der Erfindung

The invention is described in more detail with reference to the following figures.

• 1 schematic representation of a preferred embodiment of the invention

1 shows a schematic representation of a preferred embodiment of the invention. It is shown in particular how the use of a proposed system enables a safe and outpatient and / or mobile exclusion of coronary heart disease and / or a myocardial infarction. For this purpose, in the context of the invention, in particular in the context of the proposed method, individual test results, which are preferably also referred to as intermediate results, are provided, the provision of the intermediate results in particular by the components of the proposed system, in particular the means for carrying out the 22-channel Electrocardiogram, the means for performing the phonocardiography examination and the means for immediate determination of the hs troponin I value.

In the case of a patient suddenly experiencing chest or heart pain, a 4-point 22-channel electrocardiogram is preferably first carried out in the sense of the invention. If the interim result obtained suggests an acute heart disease, if necessary, an emergency doctor or an emergency medical service should be informed. In the event of a finding that initially does not allow suspicion of heart disease, the ultrasensitive phonocardiography examination and the immediate determination of the hs troponin I value can be carried out.

If the blood test leads to an inconspicuous interim result, an ST segment elevation infarction (STEMI) or a non-ST segment elevation infarction (NSTEMI) can be excluded. If the phonocardiography examination leads to an inconspicuous interim result, coronary heart disease can be excluded. If the phonocardiography examination and / or the immediate determination of the hs troponin I value in the blood lead to a conspicuous result, further diagnostic steps should be taken, with the use of the proposed system or the implementation of the proposed method in Germany alone estimated to be hundreds of thousands of treatments a year in hospitals and correspondingly many unnecessary follow-up examinations, including unnecessary diagnostic cardiac catheters, could be avoided.

Claims (5)

Mobile system for outpatient exclusion of coronary heart disease and myocardial infarction, characterized in that the system comprises means for performing a 4 point 22-channel electrocardiogram, as well as means for carrying out ultrasensitive phonocardiography examinations and means for the immediate determination of hs-troponin I. Mobile system after Claim 1 characterized in that hs-troponin I is determined as part of a point-of-care test. Using the mobile system after Claim 1 or 2nd for outpatient exclusion of coronary heart disease and a myocardial infarction. Method for providing intermediate results, characterized in that the means for performing a 4 point 22-channel electrocardiogram, the means for performing ultrasensitive phonocardiography examinations and the means for the immediate determination of hs-troponin I components of a system Claim 1 or 2nd and each deliver individual interim results that can be evaluated by an evaluation agency. Procedure according to Claim 4 characterized in that the 4 point 22-channel electrocardiogram, the ultrasensitive phonocardiography examination and the immediate determination of the hs troponin are carried out essentially simultaneously.

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