Status:
COMPLETED
Volatilome and Single-Lead Electrocardiogram Optimize Ischemic Heart Disease Diagnosis Using Machine Learning Models
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Coronary Artery Disease
Ischemic Heart Disease
Eligibility:
All Genders
40+ years
Brief Summary
This is a prospective, case-control, single-center, observational, non-randomized study. It is designed to evaluate the diagnostic accuracy of functional tests involving physical exertion monitored vi...
Detailed Description
The planned number of participants to include in the study is 80, admitted to the University Clinical Hospitals No. 1, at the I.M. Sechenov First Moscow State Medical University of the Ministry of Hea...
Eligibility Criteria
Inclusion
- Age ≥40 years;
- Absence of acute exacerbations of psychiatric disorders or cognitive impairments that would preclude study participation;
- Provision of written informed consent for study participation, blood sample collection, and anonymous publication of research results;
- Pre-test probability of ischemic heart disease between 1% and 33%.
- Non-inclusion criteria:
- Pregnancy and breastfeeding;
- Diabetes mellitus;
- Presence of acute myocardial ischemia (acute coronary syndrome or myocardial infarction within the preceding 48 hours) or a history of myocardial infarction;
- Active infectious or non-infectious inflammatory diseases in the acute/exacerbation phase;
- Connective tissue diseases (regardless of disease activity);
- Respiratory disorders (e.g., bronchial asthma, chronic bronchitis, cystic fibrosis, or other conditions associated with significant respiratory dysfunction);
- Acute pulmonary thromboembolism involving the pulmonary artery or its branches;
- Aortic dissection;
- Hemodynamically significant decompensated cardiac valvular defects\*\*;
- Active malignancy;
- Decompensated chronic heart failure (NYHA class III-IV) or acute heart failure;
- Neurological disorders (e.g., Parkinson's disease, multiple sclerosis, acute psychosis, Guillain-Barré syndrome);
- Cardiac arrhythmias or conduction abnormalities contraindicating stress testing;
- Musculoskeletal disorders precluding exercise testing (e.g., bicycle ergometry);
- Allergy to radiocontrast agents and/or adenosine triphosphate (ATP);
- Chronic kidney disease with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² (CKD-EPI formula);
- Severe hepatic insufficiency and/or Child-Pugh class B or C liver cirrhosis.
Exclusion
- Poor recording quality of single-channel electrocardiogram (ECG) and/or plethysmography data;
- Failure to complete the stress test due to reasons unrelated to cardiac conditions;
- Voluntary withdrawal of consent to continue participation in the study;
- Post-enrollment development of conditions or identification of pathologies listed in the exclusion criteria.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 10 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06181799
Start Date
November 1 2023
End Date
June 10 2024
Last Update
August 15 2025
Active Locations (1)
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1
Federal State Budgetary Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of Russia, City Clinical Hospital No. 1, Cardiology Clinic, Institute of Personalized Cardiology
Moscow, Russia, 119992