NCT07579624Not yet recruiting
AI-Enhanced Single-Lead ECG Screening for Coronary Stenosis
Screening for Significant Coronary Artery Stenosis Using Single-channel Electrocardiogram Analysis With Artificial Intelligence Elements
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 9 Feb 2026
- Start date
- 1 May 2026
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Diseases
- Coronary artery disease
- NCT number
- NCT07579624
What you commit to
- Study type: Observational
- Planned participants: 400
- From 1 May 2026 to the primary completion date, 1 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 1 University Hospital Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.