Clinical Trial

AI-Enhanced Single-Lead ECG Screening for Coronary Stenosis

Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07579624
Lead Sponsor I.M. Sechenov First Moscow State Medical University
Conditions Ischemic Heart Disease, Coronary Artery Stenosis, Stable Angina Pectoris, Acute Coronary Syndromes
Enrollment 400 participants
Start Date 2026-05-01
Primary Completion 2027-09-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-12