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Volatilome and Single-Lead Electrocardiogram Optimize Ischemic Heart Disease Diagnosis Using Machine Learning Models

CompletedNCT06181799
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 via a 12-lead ECG, combined with analysis of exhaled breath volatile organic compounds (VOCs) and single-lead ECG parameters.

Study details

Official title
Biomarkers of the Exhaled Breath and Single-Lead Electrocardiography in the Diagnosis of Myocardial Ischemia
Conditions
Interventions
  • Diagnostic test: Mass spectrometry using the PTR TOF-1000 (IONICON PTR-TOF-MS - Trace VOC Analyzer, Eduard-Bodem-Gasse 3, 6020 Innsbruck, Austria (Europe).
Sponsor
I.M. Sechenov First Moscow State Medical University
Start date
2023-11-01
Primary completion
2024-06-10
Sex
All
Age range
from 40 Years
Healthy volunteers
true
Results posted
Yes, on ClinicalTrials.gov
Countries
Russia
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Age ≥40 years; 2. Absence of acute exacerbations of psychiatric disorders or cognitive impairments that would preclude study participation; 3. Provision of written informed consent for study participation, blood sample collection, and anonymous publication of research results; 4. Pre-test probability of ischemic heart disease between 1% and 33%. Non-inclusion criteria: 1. Pregnancy and breastfeeding; 2. Diabetes mellitus; 3. Presence of acute myocardial ischemia (acute coronary syndrome or myocardial infarction within the preceding 48 hours) or a history of myocardial infarction; 4. Active infectious or non-infectious inflammatory diseases in the acute/exacerbation phase; 5. Connective tissue diseases (regardless of disease activity); 6. Respiratory disorders (e.g., bronchial asthma, chronic bronchitis, cystic fibrosis, or other conditions associated with significant respiratory dysfunction); 7. Acute pulmonary thromboembolism involving the pulmonary artery or its branches; 8. Aortic dissection; 9. Hemodynamically significant decompensated cardiac valvular defects\*\*; 10. Active malignancy; 11. Decompensated chronic heart failure (NYHA class III-IV) or acute heart failure; 12. Neurological disorders (e.g., Parkinson's disease, multiple sclerosis, acute psychosis, Guillain-Barré syndrome); 13. Cardiac arrhythmias or conduction abnormalities contraindicating stress testing; 14. Musculoskeletal disorders precluding exercise testing (e.g., bicycle ergometry); 15. Allergy to radiocontrast agents and/or adenosine triphosphate (ATP); 16. Chronic kidney disease with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² (CKD-EPI formula); 17. Severe hepatic insufficiency and/or Child-Pugh class B or C liver cirrhosis. Exclusion Criteria: 1. Poor recording quality of single-channel electrocardiogram (ECG) and/or plethysmography data; 2. Failure to complete the stress test due to reasons unrelated to cardiac conditions; 3. Voluntary withdrawal of consent to continue participation in the study; 4. Post-enrollment development of conditions or identification of pathologies listed in the exclusion criteria.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06181799