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It is a prospective, controlled, single-center, observational, non-randomized study. The study is planned to include at least 1000 patients over 18 years old in the training sample and 200 patients over 18 years old in the test sample (the total number of patients is at least 1200 people).
All patients will undergo an echocardiography examination with a comprehensive analysis of the function of the valves and other structures of the heart according to current recommendations by two independent experts.
Registration of electrocardiogram will be performed immediately after echocardiography using a single lead ECG monitor (in I standard lead) for 1 minutes.
The obtained data will be stored in the remote monitoring center of Sechenov University without being linked to the personal data of patients.
A spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform.
The result of this study will be the identification of ECG parameters that will correlate with valvular heart disease.
The aim of the study: to create and evaluate the diagnostic efficiency of a method for screening valvular heart disease based on data obtained from the analysis of a single-channel electrocardiogram.
It is a prospective, controlled, single-center, observational, non-randomized study. The study is planned to include at least 1000 patients over 18 years old in the training sample and 200 patients over 18 years old in the test sample (the total number of patients is at least 1200 people).
All subjects will undergo echocardiography with a comprehensive analysis of the function of the valves and other structures of the heart according to current recommendations by two independent experts.
Immediately after echocardiography, ECG registration will be performed in lead I for 1 minute with subsequent spectral analysis of the obtained data, which will be stored in the remote monitoring center of Sechenov University without reference to the personal data of the patients.
Single-channel ECG will be recorded using the portable single-lead ECG monitor CardioQvark. It is designed as an iPhone cover. It is registered with the Federal Service for Health Supervision on February 15, 2019. RZN No. 2019/8124.
If pathology is detected during echocardiography or ECG, the patient will be given a recommendation on the need to consult a cardiologist.
The patient's personal data (last name, first name, patronymic, date of birth, contact information) will not be transferred or taken into account. Each patient is assigned an individual number that is not associated with his/her personal data.
Then 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 analysis involves the evaluation of the following parameters (the parameters listed below will be calculated as the median of the tact-cycle):
Additionally used parameters:
Statistical analysis and modeling will be performed using Python V3.8.8 and R V.4.0 programming languages, as well as SPSS v.17 software. The correlation between various combinations of time, amplitude and frequency parameters of ECG and the presence and degree of valvular heart defects will be analyzed. Certain parameters will be included in various multivariate analysis models: Lasso regression, Random Forest, Multilayer Perceptron, Support Vector Machine and Decision Tree. The model with the highest diagnostic accuracy will be selected, on which the algorithm will be tested.
The result of this study will be the development and testing of an algorithm for identifying valvular heart disease based on the analysis of single-channel ECG parameters. With the subsequent possibility of determining the degree of valvular heart disease.
Study endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training sample | All patients over 18 years old with and without with valvular heart disease confirmed by the results of the echocardiography and by results of the spectral analysis of electrocardiogram (the parameters listed below will be calculated as the median of the tact-cycle: TpTe, VAT, QTc, QT / TQ, QRS_E, T_E, TP_E, BETA, BETA_S, BAD_T, QRS_D1_ons, QRS_D1_offs, QRS_D2, QRS_Ei (i = 1,2,3,4), T_Ei (i= 1,2,3,4), HFQRS, QRSw, RA, SA, TA and others). |
| |
| Test sample | All patients over 18 years old with and without with valvular heart disease confirmed by the results of the echocardiography and by results of the spectral analysis of electrocardiogram (the parameters listed below will be calculated as the median of the tact-cycle: TpTe, VAT, QTc, QT / TQ, QRS_E, T_E, TP_E, BETA, BETA_S, BAD_T, QRS_D1_ons, QRS_D1_offs, QRS_D2, QRS_Ei (i = 1,2,3,4), T_Ei (i= 1,2,3,4), HFQRS, QRSw, RA, SA, TA and others). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention (observational study) | Diagnostic Test | No intervention (observational study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parameters of single-channel ECG that have a reliable correlation with the presence of valvular heart defects | comparison of the presence of valvular heart defects detected by the results of an echocardiographic study with the results of the presence of valvular heart defects obtained using the mathematical model of a single-channel ECG monitor | through study completion, an average of 2 years |
| Determination of sensitivity of valvular heart defects of multivariate models for analyzing single-channel electrocardiogram data | Comparison of the presence of valvular heart defects detected by the results of an echocardiographic study with the results of the presence of valvular heart defects obtained using the mathematical model of a single-channel ECG monitor | through study completion, an average of 2 years |
| Determination of specificity of valvular heart defects of multivariate models for analyzing single-channel electrocardiogram data | Comparison of the presence of valvular heart defects detected by the results of an echocardiographic study with the results of the presence of valvular heart defects obtained using the mathematical model of a single-channel ECG monitor | through study completion, an average of 2 years |
| Determination of diagnostic accuracy of valvular heart defects of multivariate models for analyzing single-channel electrocardiogram data | Comparison of the presence of valvular heart defects detected by the results of an echocardiographic study with the results of the presence of valvular heart defects obtained using the mathematical model of a single-channel ECG monitor | through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Significance of the parameter TpTe on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter VAT on the ECG in the determination of valvular heart defects |
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Inclusion Criteria:
Exclusion Criteria:
Non-inclusion criteria:
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All patients over 18 years old
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalia Kuznetsova, Dr. | Contact | +79164778724 | kuznetsova_n_o@staff.sechenov.ru | |
| Petr Chomakhidze, Prof. | Contact | +79166740369 | chomakhidze_p_sh@staff.sechenov.ru |
| Name | Affiliation | Role |
|---|---|---|
| Philipp Kopylov, Prof. | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Study Director |
| Natalia Kuznetsova, Dr. | I.M. Sechenov First Moscow State Medical University (Sechenov University) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.M. Sechenov First Moscow State Medical University (Sechenov University) | Recruiting | Moscow | 119048 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33018287 | Background | Hata E, Seo C, Nakayama M, Iwasaki K, Ohkawauchi T, Ohya J. Classification of Aortic Stenosis Using ECG by Deep Learning and its Analysis Using Grad-CAM. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:1548-1551. doi: 10.1109/EMBC44109.2020.9175151. | |
| 35926936 | Background | Pandey A, Adedinsewo D. The Future of AI-Enhanced ECG Interpretation for Valvular Heart Disease Screening. J Am Coll Cardiol. 2022 Aug 9;80(6):627-630. doi: 10.1016/j.jacc.2022.05.034. No abstract available. |
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It is not possible to provide documentation due to the prohibition received from the local ethics committee
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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an ECG spectral analysis will be performed using the Fourier Transform |
| through study completion, an average of 2 years |
| significance of the parameter QTc on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter QT / TQ on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter QRS_E on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter TA on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter TP_E on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter BETA on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter SBETA on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter RonsF on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter RoffsF on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter PpeakP on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter QRS_Ei on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter T_Ei on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter HFQRS on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter PpeakN on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter Tenergy on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter Tpeak on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter Tons on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| significance of the parameter Toffs on the ECG in the determination of valvular heart defects | an ECG spectral analysis will be performed using the Fourier Transform | through study completion, an average of 2 years |
| D004066 | Digestive System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |