An observational study in Arterial Hypertension, Heart Rhythm Disorders and Valvular Heart Diseases, sponsored by I.M. Sechenov First Moscow State Medical University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by I.M. Sechenov First Moscow State Medical University · Observational
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
The aim of the study is to develop, evaluate the diagnostic efficacy, and pilot a screening method for cardiac and cardiac-related pathologies based on single-channel electrocardiogram analysis using artificial intelligence. To achieve this goal, a prospective, controlled, single-center, observational, non-randomized study will be conducted involving at least 4,000 patients meeting the inclusion criteria. All patients will undergo an expert echocardiography protocol with a comprehensive assessment of heart valve hemodynamics, systolic and diastolic myocardial function, along with standard measurements of the heart chambers and great vessels. To detect or exclude coronary artery disease: detection of significant coronary stenosis during coronary imaging: myocardial perfusion or determination of fractional coronary flow reserve, or stress echocardiography will be performed. For arterial hypertension: repeated blood pressure measurements in the office, 24-hour blood pressure monitoring will be performed. For cardiac arrhythmias: resting ECG and long-term Holter monitoring will be performed. For any cardiovascular pathology: blood tests: hemoglobin and red blood cell levels, glucose, glycated hemoglobin, oral glucose tolerance test, creatinine, uric acid, total cholesterol, low-density and high-density lipoproteins, and triglycerides will be performed. Additional testing data will be taken into account if conducted outside the protocol of this study. During the study, the authors will not interfere with the aforementioned scope of testing, which is performed on patients in accordance with clinical guidelines. All patients included in the study will undergo two ECG recordings in standard lead I for 1 minute, followed by spectral analysis of the obtained data, which will be stored at the remote monitoring center of Sechenov University without linking to the patients' personal data. A single-channel ECG will be recorded using a portable single-lead CardioQVARK ECG recorder. It was registered with the Federal Service for Surveillance in Healthcare on February 15, 2019. Number RU MI No. RZN 2024/22 855. The patient's personal data (last name, first name, patronymic, date of birth, contact information) will not be transferred or taken into account. Each patient is assigned an individual number that is not associated with his/her personal data. Then a spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform, the principles of which are based on the Fourier transform. The analysis involves the evaluation of the following parameters (the parameters listed below will be calculated as the median of the tact-cycle):• TpTe - time from peak to end of the T-wave• VAT - time from the beginning of the QRS to the R-peak• QTc - corrected QT interval.• QT / TQ - the ratio of QT length to TQ length (from the end of T to the beginning of the QRS of the next complex).• QRS_E - the total energy of the QRS wave based on the wavelet transform• T_E - T-wave total energy based on wavelet transform• TP_E- energy of the main tooth of the T-wave based on the wavelet transform• BETA, BETA_S - T-wave asymmetry coefficients (simple and smooth versions)• BAD_T - flag of T-wave quality (whether expressed in the current lead• QRS_D1_ons - energy of the leading edge of the R-wave (based on the "first derivative" wavelet transform)• QRS_D1_offs - energy of the trailing edge of the R-wave (based on the "first derivative" wavelet transform)• QRS_D2 - peak energy of the R-wave (based on the "second derivative" wavelet transform)• QRS_Ei (i = 1,2,3,4) - QRS-wave energy in 4 frequency ranges (2-4-8-16-32 Hz) based on wavelet transform• T_Ei (i = 1,2,3,4) - T-wave energy in 4 frequency ranges (2-4-6-8-10 Hz) based on wavelet transform• HFQRS - the amplitude of the RF components of the QRS wave. Additionally used parameters:• TpTe, VAT, QTc - are duplicated to control the correctness of the record processing (the value of the UCC should be approximately equal to the median of the tick-by-bar).• QRSw - QRS width.• RA, SA, TA - the amplitudes of the R, S, T-waves, respectively, are used to normalize the parameters listed above.Statistical analysis and modeling will be performed using Python V3.8.8 and R V.4.0, as well as SPSS v.17.The correlation between various combinations of time, amplitude and frequency parameters of ECG and the presence of cardiac and cardiac-associated pathology will be analyzed. Certain parameters will be included in various multivariate analysis models: Lasso regression, Random Forest, Multilayer Perceptron, Support Vector Machine and Decision Tree. The model with the highest diagnostic accuracy will be selected, on which the algorithm will be tested.The outcome of this study will be the development and validation of an algorithm for identifying various cardiac and cardiac-associated pathologies based on the analysis of single-channel ECG parameters. The development of a medical-use program will also be undertaken.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 350 across 1,163 observational studies indexed under Hypertension.
Browse Hypertension studies →I.M. Sechenov First Moscow State Medical University is the lead sponsor of 137 studies on the registry; 28 are open to participants now.
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All patients with or without cardiac and cardiac-associated pathologies over 18 years old
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Non-inclusion criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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).
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
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
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
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
No study locations are listed for this record.
Plan to share: No — It is not possible to provide documentation due to the prohibition received from the local ethics committee
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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