Screening of Valvular Heart Disease Using Single-channel Electrocardiogram
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.M. Sechenov First Moscow State Medical University
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
All patients over 18 years old
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention (observational study)
Diagnostic testNo intervention (observational study)
Treatment groups
1,200 Participants
are divided into 2 treatment groupsGroup A: Training sample1 intervention
Group B: Test sample1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
through study completion, an average of 2 years2
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
Time frame
through study completion, an average of 2 years3
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
Time frame
through study completion, an average of 2 years4
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
Time frame
through study completion, an average of 2 yearsSecondary outcomes
1
Significance of the parameter TpTe on the ECG in the determination of valvular heart defects
an ECG spectral analysis will be performed using the Fourier Transform
Time frame
through study completion, an average of 2 years2
significance of the parameter VAT on the ECG in the determination of valvular heart defects
an ECG spectral analysis will be performed using the Fourier Transform
Time frame
through study completion, an average of 2 years3
significance of the parameter QTc on the ECG in the determination of valvular heart defects
an ECG spectral analysis will be performed using the Fourier Transform
Time frame
through study completion, an average of 2 years4
significance of the parameter QT / TQ on the ECG in the determination of valvular heart defects
an ECG spectral analysis will be performed using the Fourier Transform
Time frame
through study completion, an average of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov