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.
Presence of written informed consent from the patient to participate in the study.
Age 18 years and older.
Outpatient visit and/or hospitalization at the research center with coronary visualization performed.
Absence of sufficient data on coronary anatomy and stenosis significance.
Patient's unwillingness to continue participation in the study.
Inability to perform full analysis of single-channel ECG digital characteristics.
Refusal of coronary visualization methods for any reason.
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.
Cohort
Prospective
single-channel electrocardiogram
Diagnostic testThe 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
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.
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