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AI-Enhanced Single-Lead ECG Screening for Coronary Stenosis

NCT07579624 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Ischemic Heart Disease
  • Coronary Artery Stenosis
  • Stable Angina Pectoris
  • Acute Coronary Syndromes

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

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-09-01
Completion
2027-12-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579624 on ClinicalTrials.gov