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AI-Enhanced Single-Lead ECG Screening for Coronary Stenosis
Sponsor: I.M. Sechenov First Moscow State Medical University
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.
Official title: Screening for Significant Coronary Artery Stenosis Using Single-channel Electrocardiogram Analysis With Artificial Intelligence Elements
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
400
Start Date
2026-05-01
Completion Date
2027-12-01
Last Updated
2026-05-12
Healthy Volunteers
No
Conditions
Interventions
single-channel electrocardiogram
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
Locations (1)
1 University Hospital
Moscow, Russia