AI-Enhanced Single-Lead ECG Screening for Coronary Stenosis

Starting soon

Conditions studied: Ischemic Heart Disease, Coronary Artery Stenosis, Stable Angina Pectoris, Acute Coronary Syndromes

In brief

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.

Key facts

Study ID

NCT07579624

Run by

I.M. Sechenov First Moscow State Medical University

People needed

400

Starts

2026-05-01

Expected to finish

2027-12-01

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Non-inclusion criteria:
• Absence of sufficient data on coronary anatomy and stenosis significance.
• Any conditions impairing the quality of single-channel ECG recording (Parkinson's disease, essential tremor, and others).
• Absence of written informed consent from the patient to participate in the study.

You may not qualify if…

• 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.

Where it is running

• 1 University Hospital — Moscow, Russia

Full record on ClinicalTrials.gov

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