AI-Enhanced Single-Lead ECG Screening for Coronary Stenosis
Russia400 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing an AI tool that analyzes a single-lead ECG to detect coronary artery narrowing — how does that approach compare to the coronary testing methods you'd already recommend for my situation, and could those give me more reliable answers sooner?
2Since this trial isn't recruiting yet, is there a realistic timeline for when it might open, and what should I be doing in the meantime to manage my heart condition while I wait?
3The trial is measuring things like sensitivity and specificity, which means it's still figuring out how accurate this AI screening tool actually is — does that mean the results wouldn't directly change my treatment plan, and if so, what would I personally get out of participating?
4My condition could fall under stable angina or acute coronary syndromes depending on how it's classified — does it matter which category I'm in when considering whether this kind of screening trial would even be appropriate for me?
5Because this is a diagnostic screening study rather than a treatment trial, can you help me understand whether joining would run alongside my normal care or whether it might delay or complicate getting treatment I might already need?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity, specificity, positive/negative predictive values, and overall accuracy
Timeframe: From July 2027 to August 2027
Trial details
NCT IDNCT07579624
SponsorI.M. Sechenov First Moscow State Medical University