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AI-Enhanced Single-Lead ECG Screening for Coronary Stenosis

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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
(from sponsor)
Ischemic Heart Disease, Coronary Artery Stenosis, Stable Angina Pectoris, Acute Coronary Syndromes
Related terms Acute Coronary Syndrome, Angina Pectoris, Angina, Stable, Coronary Stenosis, Myocardial Ischemia
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov