NCT07099417 Screening of Valvular Heart Disease Using Single-channel Electrocardiogram
| NCT ID | NCT07099417 |
| Status | Recruiting |
| Phase | — |
| Sponsor | I.M. Sechenov First Moscow State Medical University |
| Condition | Valvular Heart Disease Stenosis and Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2025-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. Non-inclusion criteria: * 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
Contact & Investigator
Philipp Kopylov, Prof.
STUDY DIRECTOR
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Frequently Asked Questions
Who can join the NCT07099417 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Valvular Heart Disease Stenosis and Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07099417 currently recruiting?
Yes, NCT07099417 is actively recruiting participants. Contact the research team at kuznetsova_n_o@staff.sechenov.ru for enrollment information.
Where is the NCT07099417 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT07099417 clinical trial?
NCT07099417 is sponsored by I.M. Sechenov First Moscow State Medical University. The principal investigator is Philipp Kopylov, Prof. at I.M. Sechenov First Moscow State Medical University (Sechenov University). The trial plans to enroll 1,200 participants.