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This is a prospective, single-center, non-randomized, observational study. The aim of this study is to determine the potential of a single-lead electrocardiogram monitor CardioQvark with photoplethysmography function use to evaluate systolic function of the left ventricle.
The study is conducted in the clinic of I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia. It is planned to include 400 patients. Recording of the electrocardiogram and photoplethysmogram by the monitor CardioQvark and the assessment of systolic function using echocardiography will be performed in all study participants.
The result of this study will be the identification of the parameters of the pulse wave and electrocardiogram that will correlate with systolic function of the left ventricle. It is also planned to determine the diagnostic effectiveness of this method.
The aim of this study is to determine the potential of a single-lead electrocardiogram (ECG) monitor CardioQvark (Moscow, Russia) with photoplethysmography function use to evaluate parameters systolic function of the left ventricle. Also according to the photoplethysmogram (PPG), using a special algorithm, the levels of systolic and diastolic blood pressure are calculated.
The single-lead electrocardiogram monitor CardioQvark (it is registered with the Federal Service for Health Supervision on February 15, 2019. RZN (Roszdravnadzor) No. 2019/8124) looks like an iPhone cover and records electrocardiogram (I standard lead) and photoplethysmogram (pulse wave) simultaneously.
This is a prospective, single-center, non-randomized, observational study. The investigators are planning to include in the study 400 patients with different pathologies of the cardiovascular system (coronary artery disease, hypertension, valvular heart disease, heart failure) according to the inclusion criteria.
Collection of medical history; physical examination (including inspection, palpation and auscultation, as well as determination of breathing rate, pulse rate, height, and weight) will be performed for the entire group of patients. Electrocardiogram and photoplethysmogram registration and assessment of the blood pressure using a CardioQvark monitor will be performed on all study participants at rest (the patient will sit quietly for 10-15 minutes before the examination). The reference blood pressure will be measured using a cuff-based blood pressure device ("Microlife BP AG1-10") that is worn on the upper arm according to the World Health Organization recommendations.
All subjects will undergo an echocardiography ("Dimension/Vivid 7 PRO General Electric Medical System"), the examination will be performed by an experienced doctor (the doctor will not have data on the parameters of the pulse wave and electrocardiogram). The extended protocol echocardiography will be performed according to the recommendations of European Association of Cardiovascular Imaging (EACVI) and American Society of Echocardiography (ASE). All examinations will be performed consistently within one day.
All electrocardiograms and photoplethysmograms records will be sent to the CardioQVARK server and processed by the algorithm using signal processing based on the wavelet transformation. Then engineers of "CardioQvark" (Limited Liability Company) will calculate the pulse wave parameters:
A spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform, the principles of which are based on the Fourier transform:
The investigators will evaluate parameters of the pulse wave (photoplethysmogram) and electrocardiogram and compare the results with echocardiography (ejection fraction, left ventricular outflow tract velocity time integral (VTI), left ventricular global longitudinal strain (GLS)).The mathematical model for determining the systolic dysfunction of the left ventricle will be built on the basis of the parameters of the photoplethysmogram and the electrocardiogram.
Intergroup analysis of significant differences, correlation analysis and Bland-Altman method will be used for statistical data analysis. All statistical analyses will be perform using a computer program for statistical processing of data SPPS (statistical package for the social sciences) Statistics Version 26.
It is planned to obtain comparative characteristics of the pulse wave and electrocardiogram parameters registered by the CardioQvark monitor and the indicators of systolic function of the left ventricle detected during echocardiography. The result of this study will be the identification of the parameters of the pulse wave and electrocardiogram that will correlate with systolic dysfunction of the left ventricle. It is planned to determine the diagnostic effectiveness of this method. The accuracy of the blood pressure measurement using the CardioQvark monitor will also be evaluated.
Thus, a quick and convenient assessment of systolic function of the left ventricle and blood pressure measurement will be available. So, study results will improve the diagnosis and treatment of cardiovascular disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with and without left ventricular systolic dysfunction | Patients with different pathologies of the cardiovascular system (coronary artery disease, hypertension, valvular heart disease, heart failure) will be performed pulse wave recording using a CardioQvark cardiomonitor and echocardiography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulse wave recording, echocardiography. | Device | pulse wave recording using a single-channel electrocardiogram cardiomonitor with photoplethysmography, conducting echocardiography according to a standard protocol with the determination of systolic function of the left ventricle |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the comparative characteristics of the pulse wave parameters registered by a single- lead ECG monitor CardioQvark and indicators of systolic function of the left ventricle detected during echocardiography. | comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters. | Through study completion, an average of 1 year. |
| Diagnostic accuracy of the pulse wave and electrocardiogram parameters registered by a single- lead ECG monitor CardioQvark. | comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters. | Through study completion, an average of 1 year. |
| Determination of the sensitivity of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single- lead ECG monitor CardioQvark. | comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters. | Through study completion, an average of 1 year. |
| Determination of specificity of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single- lead ECG monitor CardioQvark. | comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters. | Through study completion, an average of 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| significance of the parameter TpTe on the ECG in the determination of left ventricular systolic dysfunction | an ECG spectral analysis will be performed using the Fourier Transform | Through study completion, an average of 1 year. |
| significance of the parameter VAT on the ECG in the determination of left ventricular systolic dysfunction |
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Inclusion Criteria:
The presence of written informed consent of the patient to participate in the study.
The presence of diagnosed cardiac pathology according anamnesis (coronary artery disease (I-IV classes according Canadian Cardiovascular Society grading of angina pectoris, post myocardial infarction, patients after percutaneous coronary intervention or coronary artery bypass grafting); hypertension (stages I- III); valvular heart disease (except patients with aortic valve stenosis and mechanical prosthetic heart valve); heart failure (I-IV NYHA).
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Exclusion Criteria:
1. Patient's reluctance to participate in the study. 2. Poor quality of ECG recording by a single-channel ECG monitor. 3. Poor visualization of the heart during echocardiography.
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Non-inclusion criteria:
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Patients with different pathologies of the cardiovascular system (coronary artery disease, hypertension, valvular heart disease, heart failure) aged 18 years and older.
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| Name | Affiliation | Role |
|---|---|---|
| Petr Chomakhidze, Professor | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Study Director |
| Zhanna Sagirova, Graduate | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.M. Sechenov First Moscow State Medical University (Sechenov University) | Moscow | Russia |
The research sponsor is Sechenov University. Data disclosure is not permitted by the local ethics committee. For more information about the study, you need to contact the principal investigator.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D001795 | Blood Pressure Determination |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Determination of prognostic value of positive and negative results of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single-channel ECG monitor CardioQvark. |
comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters. |
| Through study completion, an average of 1 year. |
| Determination of area under receiver operating characteristic curve of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single- lead ECG monitor CardioQvark. | comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters. | Through study completion, an average of 1 year. |
| Determination of correlation coefficient of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single-channel ECG monitor CardioQvark. | comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters. | Through study completion, an average of 1 year. |
| assessment of the accuracy of the blood pressure measurement using a single-channel ECG monitor CardioQvark. | comparison of blood pressure values obtained on the basis of a mathematical model of pulse wave parameters and measured using a cuff-based device. | Through study completion, an average of 1 year. |
an ECG spectral analysis will be performed using the Fourier Transform |
| Through study completion, an average of 1 year. |
| significance of the parameter QTc on the ECG in the determination of left ventricular systolic dysfunction | an ECG spectral analysis will be performed using the Fourier Transform | Through study completion, an average of 1 year. |
| significance of the parameter QT / TQ on the ECG in the determination of left ventricular systolic dysfunction | an ECG spectral analysis will be performed using the Fourier Transform | Through study completion, an average of 1 year. |
| significance of the parameter QRS_E on the ECG in the determination of left ventricular systolic dysfunction | an ECG spectral analysis will be performed using the Fourier Transform | Through study completion, an average of 1 year. |
| significance of the parameter T_E on the ECG in the determination of left ventricular systolic dysfunction | an ECG spectral analysis will be performed using the Fourier Transform | Through study completion, an average of 1 year. |
| significance of the parameter TP_E on the ECG in the determination of left ventricular systolic dysfunction | an ECG spectral analysis will be performed using the Fourier Transform | Through study completion, an average of 1 year. |
| significance of the parameter BETA on the ECG in the determination of left ventricular systolic dysfunction | an ECG spectral analysis will be performed using the Fourier Transform | Through study completion, an average of 1 year. |
| significance of the parameter BETA_S on the ECG in the determination of left ventricular systolic dysfunction | an ECG spectral analysis will be performed using the Fourier Transform | Through study completion, an average of 1 year. |
| significance of the parameter BAD_T on the ECG in the determination of left ventricular systolic dysfunction | an ECG spectral analysis will be performed using the Fourier Transform | Through study completion, an average of 1 year. |
| significance of the parameter QRS_D1_ons on the ECG in the determination of left ventricular systolic dysfunction | an ECG spectral analysis will be performed using the Fourier Transform | Through study completion, an average of 1 year. |
| significance of the parameter QRS_D1_offs on the ECG in the determination of left ventricular systolic dysfunction | an ECG spectral analysis will be performed using the Fourier Transform | Through study completion, an average of 1 year. |
| significance of the parameter QRS_D2 on the ECG in the determination of left ventricular systolic dysfunction | an ECG spectral analysis will be performed using the Fourier Transform | Through study completion, an average of 1 year. |
| significance of the parameter QRS_Ei on the ECG in the determination of left ventricular systolic dysfunction | an ECG spectral analysis will be performed using the Fourier Transform | Through study completion, an average of 1 year. |
| significance of the parameter T_Ei on the ECG in the determination of left ventricular systolic dysfunction | an ECG spectral analysis will be performed using the Fourier Transform | Through study completion, an average of 1 year. |
| significance of the parameter HFQRS on the ECG in the determination of left ventricular systolic dysfunction | an ECG spectral analysis will be performed using the Fourier Transform | Through study completion, an average of 1 year. |
| significance of the parameter B1 on the pulse wave in the determination of left ventricular systolic dysfunction | the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark | Through study completion, an average of 1 year. |
| significance of the parameter B0 on the pulse wave in the determination of left ventricular systolic dysfunction | the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark | Through study completion, an average of 1 year. |
| significance of the parameter SEP on the pulse wave in the determination of left ventricular systolic dysfunction | the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark | Through study completion, an average of 1 year. |
| significance of the parameter DER3 on the pulse wave in the determination of left ventricular systolic dysfunction | the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark | Through study completion, an average of 1 year. |
| significance of the parameter SEPMAX on the pulse wave in the determination of left ventricular systolic dysfunction | the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark | Through study completion, an average of 1 year. |
| significance of the parameter SRP on the pulse wave in the determination of left ventricular systolic dysfunction | the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark | Through study completion, an average of 1 year. |
| significance of the parameter DP on the pulse wave in the determination of left ventricular systolic dysfunction | the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark | Through study completion, an average of 1 year. |
| significance of the parameter perfusion index on the pulse wave in the determination of left ventricular systolic dysfunction | the analysis of the pulse wave registered by a single-lead ECG monitor with the photoplethysmography CardioQvark | Through study completion, an average of 1 year. |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D010808 | Physical Examination |