Screening for Cardiac and Cardiac-associated Pathology Using Single-channel Electrocardiogram

Trial statusNot yet recruiting
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 4000 patients 18 years old and older in the training sample and 1000 patients over 18 years old in the test sample (the total number of patients is at least 5000 people). Patients will be included in the study if they have undergone a full examination (laboratory, clinical and instrumental), allowing for the verification or exclusion of cardiac and cardiac-associated pathology in accordance with current recommendations. During the course of the study, the authors of the work do not interfere with the above-mentioned scope of the examination, which is carried out on patients in accordance with clinical guidelines. All patients included in the study will undergo ECG recording in standard lead I for 1 minute twice, followed by spectral analysis of the obtained data, which will be stored at 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 cardiac and cardiac-associated pathology

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The presence of written informed consent of the patient to participate in the study

Availability of examination data allowing for the verification or exclusion of cardiac and cardiac-associated pathology

Age 18 years old and older

Patients with an implanted permanent pacemaker;

Disqualifiers

Poor quality of the ECG recording on a single-channel ECG monitor

Insufficient examination data to verify or exclude cardiac or cardiac-associated pathology;

Patient's unwillingness to continue participating in the study for any reason.

Trial population

All patients with or without cardiac and cardiac-associated pathologies over 18 years old

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

4,000 Participants
are grouped into 2 trial groups
Group A: Training sample
Group B: Test sample

Trial outcomes

Primary outcomes

1

Parameters of single-channel ECG that significantly correlate with the presence of various cardiac and cardiac-associated pathologies

comparison of the presence of cardiac and cardiac-associated pathology by the results of full examination (laboratory, clinical and instrumental) 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 years
2

Determination of sensitivity of various cardiac and cardiac-associated pathologies of multivariate models for analyzing single-channel electrocardiogram data

comparison of the presence of cardiac and cardiac-associated pathology by the results of full examination (laboratory, clinical and instrumental) 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 years
3

Determination of specificity of various cardiac and cardiac-associated pathologies of multivariate models for analyzing single-channel electrocardiogram data

comparison of the presence of cardiac and cardiac-associated pathology by the results of full examination (laboratory, clinical and instrumental) 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 years
4

Determination of diagnostic accuracy of various cardiac and cardiac-associated pathologies of multivariate models for analyzing single-channel electrocardiogram data

comparison of the presence of cardiac and cardiac-associated pathology by the results of full examination (laboratory, clinical and instrumental) 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 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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