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

Sponsor
I.M. Sechenov First Moscow State Medical University
Study ID
NCT07396792
Status
Not Yet Recruiting

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Conditions

  • Arterial Hypertension
  • Chronic Kidney Disease (Stage 3-4)
  • Coronary Artery Disease
  • Diabetes Mellitus
  • Heart Failure
  • Heart Rhythm Disorders
  • Metabolic Syndrome
  • Valvular Heart Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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

Key Dates

First listed
Feb 9, 2026
Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Mar 1, 2028
Completion
May 13, 2028

Study Design

Enrollment
4,000 participants (estimated)

Arms

  • Arm: Training sample
    2500 of patients 18 years old and older with and without cardiac and cardiac-associated pathology confirmed by the results of full examination (laboratory, clinical and instrumental) and by results of the spectral analysis of electrocardiogram (the parameters listed below will be calculated as the median of the tact-cycle: TpTe, VAT, QTc, QT / TQ, QRS\_E, T\_E, TP\_E, BETA, BETA\_S, BAD\_T, QRS\_D1\_ons, QRS\_D1\_offs, QRS\_D2, QRS\_Ei (i = 1,2,3,4), T\_Ei (i= 1,2,3,4), HFQRS, QRSw, RA, SA, TA and others).
  • Arm: Test sample
    1500 of patients 18 years old and older with and without cardiac and cardiac-associated pathology confirmed by the results of full examination (laboratory, clinical and instrumental) and by results of the spectral analysis of electrocardiogram (the parameters listed below will be calculated as the median of the tact-cycle: TpTe, VAT, QTc, QT / TQ, QRS\_E, T\_E, TP\_E, BETA, BETA\_S, BAD\_T, QRS\_D1\_ons, QRS\_D1\_offs, QRS\_D2, QRS\_Ei (i = 1,2,3,4), T\_Ei (i= 1,2,3,4), HFQRS, QRSw, RA, SA, TA and others).

Primary Outcome Measure

Parameters of single-channel ECG that significantly correlate with the presence of various cardiac and cardiac-associated pathologies [ Time Frame: through study completion, an average of 2 years ]

Central Contacts

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