AI-Enhanced Single-Lead ECG Screening for Coronary Stenosis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.M. Sechenov First Moscow State Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Absence of sufficient data on coronary anatomy and stenosis significance.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • single-channel electrocardiogram

Treatment groups

400 Participants
are divided into 2 treatment groups