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AI-Based Screening for Cardiac Pathology Using Single-Channel Electrocardiogram

Study Aim

This observational study aims to determine the accuracy, sensitivity, and specificity of an AI-based mathematical model in detecting various cardiac and cardiac-associated pathologies using single-channel electrocardiogram data, and to identify significant ECG parameters that correlate with these conditions.

What is being collected

Data Collection

Collected from today forward - Prospective

Who is being recruted

Urogenital Diseases+36

+ Anemia

+ Arrhythmias, Cardiac

Over 18 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.

Observational

Study Start: March 2026

See protocol details

Summary

Principal SponsorI.M. Sechenov First Moscow State Medical University

Study ContactNatalia Kuznetsova, Dr.More contacts

Last updated: February 10, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2026

Actual date on which the first participant was enrolled.

This study aims to create and evaluate a new method for detecting heart and heart-related conditions. The method uses a single-channel electrocardiogram (ECG) analyzed with machine learning models, a type of artificial intelligence. The study plans to include at least 5000 patients over 18 years old. The goal is to improve the detection of heart conditions, addressing a significant health challenge. This study could potentially lead to better care for patients with heart conditions. During the study, participants will undergo a full examination, including laboratory, clinical, and instrumental tests. This will confirm or rule out heart and heart-related conditions. The ECG will be recorded using a portable single-lead ECG monitor, CardioQvark, designed as an iPhone cover. The recorded ECG data will be analyzed using a spectral analysis method. This study does not interfere with any clinical guidelines for patient examination. The study will identify single-channel ECG parameters that significantly correlate with the presence of various heart and heart-related conditions. It will also determine the sensitivity, specificity, and diagnostic accuracy of multivariate models for analyzing single-channel ECG data.

Official TitleScreening for Cardiac and Cardiac-associated Pathology Using Single-channel Electrocardiogram Analyzed With Machine Learning Models

NCT07396792

Principal SponsorI.M. Sechenov First Moscow State Medical University

Study ContactNatalia Kuznetsova, Dr.More contacts

Last updated: February 10, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

4000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAnemiaArrhythmias, CardiacArterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesChronic DiseaseCoronary Artery DiseaseCoronary DiseaseDiabetes MellitusEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsHeart DiseasesHeart FailureHeart Valve DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHypercholesterolemiaHyperinsulinismHyperlipidemiasHypertensionInsulin ResistanceKidney DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesVascular DiseasesMyocardial IschemiaDisease AttributesMetabolic SyndromeGlucose Metabolism DisordersDyslipidemiasRenal Insufficiency, ChronicRenal InsufficiencyLipid Metabolism DisordersFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

3 inclusion criteria required to participate

Age 18 years old and older

Availability of examination data allowing for the verification or exclusion of cardiac and cardiac-associated pathology

The presence of written informed consent of the patient to participate in the study

8 exclusion criteria prevent from participating

Insufficient examination data to verify or exclude cardiac or cardiac-associated pathology

Patient's unwillingness to continue participating in the study for any reason

Patients with an implanted permanent pacemaker

ECG changes that prevent spectral analysis

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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Recruiting soonNo study centers