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NOT YET RECRUITING
NCT07579624

AI-Enhanced Single-Lead ECG Screening for Coronary Stenosis

Sponsor: I.M. Sechenov First Moscow State Medical University

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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