Screening of Valvular Heart Disease Using Single-channel Electrocardiogram

NCT07099417 | Recruiting

• 1 other identifier: 29-24
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

It is a prospective, controlled, single-center, observational, non-randomized study. The study is planned to include at least 1000 patients over 18 years old in the training sample and 200 patients over 18 years old in the test sample (the total number of patients is at least 1200 people). All patients will undergo an echocardiography examination with a comprehensive analysis of the function of the valves and other structures of the heart according to current recommendations by two independent experts. Registration of electrocardiogram will be performed immediately after echocardiography using a single lead ECG monitor (in I standard lead) for 1 minutes. The obtained data will be stored in 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 will correlate with valvular heart disease.

Conditions

Valvular Heart Disease Stenosis and Regurgitation; Valvular Heart Disease

Keywords

valvular heart disease; Screening; single-channel electrocardiogram; machine learning models

Outcome Measures

Primary Outcomes (4)

• Parameters of single-channel ECG that have a reliable correlation with the presence of valvular heart defects

  comparison of the presence of valvular heart defects detected by the results of an echocardiographic study with the results of the presence of valvular heart defects obtained using the mathematical model of a single-channel ECG monitor

  through study completion, an average of 2 years

• Determination of sensitivity of valvular heart defects of multivariate models for analyzing single-channel electrocardiogram data

  Comparison of the presence of valvular heart defects detected by the results of an echocardiographic study with the results of the presence of valvular heart defects obtained using the mathematical model of a single-channel ECG monitor

  through study completion, an average of 2 years

• Determination of specificity of valvular heart defects of multivariate models for analyzing single-channel electrocardiogram data

  Comparison of the presence of valvular heart defects detected by the results of an echocardiographic study with the results of the presence of valvular heart defects obtained using the mathematical model of a single-channel ECG monitor

  through study completion, an average of 2 years

• Determination of diagnostic accuracy of valvular heart defects of multivariate models for analyzing single-channel electrocardiogram data

  Comparison of the presence of valvular heart defects detected by the results of an echocardiographic study with the results of the presence of valvular heart defects obtained using the mathematical model of a single-channel ECG monitor

  through study completion, an average of 2 years

Secondary Outcomes (20)

• Significance of the parameter TpTe on the ECG in the determination of valvular heart defects

  through study completion, an average of 2 years

• significance of the parameter VAT on the ECG in the determination of valvular heart defects

  through study completion, an average of 2 years

• significance of the parameter QTc on the ECG in the determination of valvular heart defects

  through study completion, an average of 2 years

• significance of the parameter QT / TQ on the ECG in the determination of valvular heart defects

  through study completion, an average of 2 years

• significance of the parameter QRS_E on the ECG in the determination of valvular heart defects

  through study completion, an average of 2 years

Study Arms (2)

Training sample

All patients over 18 years old with and without with valvular heart disease confirmed by the results of the echocardiography and by results of the spectral analysis of electrocardiogram (the parameters listed below will be calculated as the median of the tact-cycle: TpTe, VAT, QTc, QT / TQ, QRS\_E, T\_E, TP\_E, BETA, BETA\_S, BAD\_T, QRS\_D1\_ons, QRS\_D1\_offs, QRS\_D2, QRS\_Ei (i = 1,2,3,4), T\_Ei (i= 1,2,3,4), HFQRS, QRSw, RA, SA, TA and others).

Diagnostic Test: No intervention (observational study)

Test sample

All patients over 18 years old with and without with valvular heart disease confirmed by the results of the echocardiography and by results of the spectral analysis of electrocardiogram (the parameters listed below will be calculated as the median of the tact-cycle: TpTe, VAT, QTc, QT / TQ, QRS\_E, T\_E, TP\_E, BETA, BETA\_S, BAD\_T, QRS\_D1\_ons, QRS\_D1\_offs, QRS\_D2, QRS\_Ei (i = 1,2,3,4), T\_Ei (i= 1,2,3,4), HFQRS, QRSw, RA, SA, TA and others).

Diagnostic Test: No intervention (observational study)

Interventions

No intervention (observational study) DIAGNOSTIC_TEST

No intervention (observational study)

Test sample; Training sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients over 18 years old

You may qualify if:

• The presence of written informed consent of the patient to participate in the study
• Age from 18 years
• Outpatient treatment and / or hospitalization in a research center

You may not qualify if:

• Reluctance of the patient to participate in the study
• Poor quality ECG recording on a single-channel ECG monitor
• Poor visualization of the heart during echocardiographic study
• Acute psychotic reactions that arose during research
• An exacerbation of chronic diseases requiring treatment tactics for the patient and preventing his further participation in the study.
• Poor quality ECG recording on a single-channel ECG monitor
• Conditions that can impair ECG recording quality (Parkinson's disease, essential tremor)
• Mental illness
• Patients with a pacemaker installed
• Patients with prosthetic valves

Sponsors & Collaborators

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

Study Sites (1)

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, 119048, Russia

RECRUITING

Related Publications (2)

• Hata E, Seo C, Nakayama M, Iwasaki K, Ohkawauchi T, Ohya J. Classification of Aortic Stenosis Using ECG by Deep Learning and its Analysis Using Grad-CAM. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:1548-1551. doi: 10.1109/EMBC44109.2020.9175151.

  PMID: 33018287 BACKGROUND

• Pandey A, Adedinsewo D. The Future of AI-Enhanced ECG Interpretation for Valvular Heart Disease Screening. J Am Coll Cardiol. 2022 Aug 9;80(6):627-630. doi: 10.1016/j.jacc.2022.05.034. No abstract available.

  PMID: 35926936 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Philipp Kopylov, Prof.

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  STUDY DIRECTOR

• Natalia Kuznetsova, Dr.

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Kuznetsova, Dr.

CONTACT

+79164778724; kuznetsova_n_o@staff.sechenov.ru

Petr Chomakhidze, Prof.

CONTACT

+79166740369; chomakhidze_p_sh@staff.sechenov.ru

Study Design

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

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)