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Screening of Valvular Heart Disease Using Single-channel Electrocardiogram

Recruitingn/aAges 18 Years - anyAllI.M. Sechenov First Moscow State Medical Universi…
NCT07099417 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • No intervention (observational study)
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Where

1 site
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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