Valvular Heart Disease Detection via Machine Learning Analysis of Single-Channel ECG
This study uses machine learning to analyze single-channel ECGs and identify parameters correlated with valvular heart disease. We aim to determine the sensitivity, specificity, and diagnostic accuracy of this method.
Data Collection
Collected from today forward - ProspectiveCardiovascular Diseases+6
+ Deglutition Disorders
+ Digestive System Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: January 1, 2025
Actual date on which the first participant was enrolled.This study aims to improve the way doctors detect valvular heart disease, a condition affecting the heart's valves, by using a single-channel electrocardiogram (ECG) analyzed with machine learning models. The study involves both a training group of at least 1000 adults and a testing group of 200 adults, all over 18 years old. Valvular heart disease can lead to serious health issues if not diagnosed early, so finding a more efficient and accurate screening method is crucial. By developing a new algorithm, the study hopes to better identify these heart issues using simpler and more accessible technology. Participants in the study will undergo a standard heart ultrasound called echocardiography to thoroughly examine their heart valves. Afterwards, a one-minute ECG will be recorded using a device that doubles as an iPhone cover. This data will then be analyzed using advanced mathematical methods to find patterns associated with heart valve problems. The study will evaluate how well these patterns match up with the results from the echocardiography to determine the accuracy of the new method. The ultimate goal is to create a reliable tool that can help doctors diagnose valvular heart disease with greater precision, potentially leading to earlier and more effective treatment for patients.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary 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.This study has 1 location
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, RussiaOpen I.M. Sechenov First Moscow State Medical University (Sechenov University) in Google Maps