AI-Enhanced Single-Lead ECG Screening for Coronary Stenosis

NCT07579624 | Not Yet Recruiting

• 1 other identifier: ChPSH22261
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

coronary; Ischemic Heart Disease; Single-Channel ECG; Artificial Intelligence; AI-Enhanced Screening; Non-Invasive Diagnostics; Angina

Outcome Measures

Primary Outcomes (1)

• Sensitivity, specificity, positive/negative predictive values, and overall accuracy

  Sensitivity, specificity, positive/negative predictive values, and overall accuracy will be derived by comparing model predictions of significant coronary stenosis (≥50% lumen narrowing per CAG/MSCT) against the gold standard, with cross-validation (k=5 folds) to ensure robustness and bootstrap resampling for 95% confidence intervals.

  From July 2027 to August 2027

Study Arms (2)

coronary artery stenosis

200 patients with significant coronary artery stenosis confirmed by coronary angiography (CAG) or multislice computed tomography (MSCT) results

Diagnostic Test: single-channel electrocardiogram

control group

200 patients without significant stenosis according to CAG or MSCT data

Diagnostic Test: single-channel electrocardiogram

Interventions

single-channel electrocardiogram DIAGNOSTIC_TEST

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

control group; coronary artery stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 clinically indicated. ECG registration in standard lead I will be performed within 3 months before or after the CAG or MSCT.

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.
• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

1 University Hospital

Moscow, 119435, Russia

Location

Related Publications (2)

• Analysis of transitions between linear and nonlinear cardiac rhythm modes in patients with ischemic heart disease / L. V. Mezentseva, P. Sh. Chomakhidze, F. Yu. Kopylov [et al.] // Pathogenesis. - 2017. - Vol. 15, No. 1. - P. 54-58. - DOI 10.25557/GM.2017.1.6952. - EDN ZFALML.

  BACKGROUND

• Simakov, Sergey, Gamilov, Timur, Danilov, Alexander, Kopylov, Philipp, Chomakhidze, Peter and Liang, Fuyou. "Hemodynamics in residual myocardial ischemia". BIOKYBERNETIKA: Mathematics for Theory and Control in the Human and in Society, edited by Jochen Mau, Sergey Mukhin, Guanyu Wang and Shuhua Xu, Berlin, Boston: De Gruyter, 2025, pp. 319-334. https://doi.org/10.1515/9783111341996-017

  BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Stenosis; Angina, Stable; Acute Coronary Syndrome; Angina Pectoris

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Petr Chomakhidze, Professor

CONTACT

+79166740369; chomakhidze_p_sh@staff.sechenov.ru

Liana Khromova, Dr.

CONTACT

+79083018204; liana.khromova@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)