Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
It is a prospective, controlled, single-center, non-randomized, observational study. Two patient groups are planned for inclusion: the first - 200 patients with significant coronary artery stenosis confirmed by coronary angiography (CAG) or multislice computed tomography (MSCT) results; the second - a control group consisting of 200 patients without significant stenosis according to CAG or MSCT data.
All study subjects will have a date of coronary artery imaging via CAG or MSCT with assessment of myocardial perfusion.
Stress echocardiography tests or fractional flow reserve (FFR) assessment will be conducted as indicated.
All patients included in the study will undergo ECG recording within 1 month before or after CAG or MSCT in standard lead I for 1 minute, followed by spectral analysis of the obtained data, which will be stored at 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 correlate with significant coronary artery stenosis.
The aim of the study:: To develop and evaluate the diagnostic efficacy of a screening method for significant coronary artery stenosis based on data obtained from the analysis of a single-channel electrocardiogram.
This is a prospective, controlled, single-center, non-randomized, observational study. Two patient groups are planned for inclusion: the first group comprises 200 patients with significant coronary artery stenosis confirmed by coronary angiography (CAG) or multislice computed tomography (MSCT) results; the second group is a control group consisting of 200 patients without significant stenosis according to CAG or MSCT data.
All study subjects will have a date of coronary artery imaging via CAG or MSCT with assessment of myocardial perfusion. Stress echocardiography tests or fractional flow reserve (FFR) assessment will be conducted as clinically indicated. ECG registration in standard lead I will be performed within 3 months before or after the CAG or MSCT.
Obtained data will be stored at 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 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 Surveillance on February 15, 2019. RZN No. 2019/8124.
The result of this study will be the identification of ECG parameters that correlate with significant coronary artery stenosis.
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.
Subsequently, spectral analysis of the electrocardiogram will be performed using machine learning models and/or neural network data analysis.
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.
Analysis of the single-channel ECG involves evaluation of the following parameters (the parameters listed below will be calculated as median beat-to-beat values):
Additionally used parameters:
Method of statistical processing of results: SPSS Statistics Version 26 computer program for statistical data processing; construction of machine learning models and/or neural network data analysis The proposed research outcome: development of an algorithm for diagnosing significant coronary stenosis based on single-channel ECG data using elements of artificial intelligence.
The endpoints of the study are the parameters of diagnostic accuracy of the developed model:
Тhese metrics will be calculated using receiver operating characteristic (ROC) analysis and confusion matrices on a held-out test set (30% of the dataset) after training multifactorial models (logistic regression, random forest, or neural networks) on single-lead ECG features. Sensitivity, specificity, positive/negative predictive values, and overall accuracy will be derived by comparing model predictions of significant coronary stenosis (≥50% lumen narrowing per CAG/MSCT) against the gold standard, with cross-validation (k=5 folds) to ensure robustness and bootstrap resampling for 95% confidence intervals.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| coronary artery stenosis | 200 patients with significant coronary artery stenosis confirmed by coronary angiography (CAG) or multislice computed tomography (MSCT) results |
| |
| control group | 200 patients without significant stenosis according to CAG or MSCT data |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single-channel electrocardiogram | Diagnostic Test | The 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 Surveillance on February 15, 2019. RZN No. 2019/8124 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity, positive/negative predictive values, and overall accuracy | Sensitivity, specificity, positive/negative predictive values, and overall accuracy will be derived by comparing model predictions of significant coronary stenosis (≥50% lumen narrowing per CAG/MSCT) against the gold standard, with cross-validation (k=5 folds) to ensure robustness and bootstrap resampling for 95% confidence intervals. | From July 2027 to August 2027 |
Not provided
Not provided
Inclusion Criteria:
Non-inclusion criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All study subjects will have a date of coronary artery imaging via CAG or MSCT with assessment of myocardial perfusion. Stress echocardiography tests or fractional flow reserve (FFR) assessment will be conducted as clinically indicated. ECG registration in standard lead I will be performed within 3 months before or after the CAG or MSCT.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Petr Chomakhidze, Professor | Contact | +79166740369 | chomakhidze_p_sh@staff.sechenov.ru | |
| Liana Khromova, Dr. | Contact | +79083018204 | liana.khromova@mail.ru |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1 University Hospital | Moscow | 119435 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Analysis of transitions between linear and nonlinear cardiac rhythm modes in patients with ischemic heart disease / L. V. Mezentseva, P. Sh. Chomakhidze, F. Yu. Kopylov [et al.] // Pathogenesis. - 2017. - Vol. 15, No. 1. - P. 54-58. - DOI 10.25557/GM.2017.1.6952. - EDN ZFALML. | ||
| Background | Simakov, Sergey, Gamilov, Timur, Danilov, Alexander, Kopylov, Philipp, Chomakhidze, Peter and Liang, Fuyou. "Hemodynamics in residual myocardial ischemia". BIOKYBERNETIKA: Mathematics for Theory and Control in the Human and in Society, edited by Jochen Mau, Sergey Mukhin, Guanyu Wang and Shuhua Xu, Berlin, Boston: De Gruyter, 2025, pp. 319-334. https://doi.org/10.1515/9783111341996-017 |
Not provided
Not provided
It is not possible to provide documentation due to the prohibition received from the local ethics committee
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D023921 | Coronary Stenosis |
| D060050 | Angina, Stable |
| D054058 | Acute Coronary Syndrome |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |