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NCT06181799Completed

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

Biomarkers of the Exhaled Breath and Single-Lead Electrocardiography in the Diagnosis of Myocardial Ischemia

Source: ClinicalTrials.gov · Last updated 15 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
80 (actual)
First submitted
13 Dec 2023
Start date
1 Nov 2023
Primary completion date
10 Jun 2024
Lead sponsor
I.M. Sechenov First Moscow State Medical University
NCT number
NCT06181799

What you commit to

  • Study type: Observational
  • Participants enrolled: 80
  • From 1 Nov 2023 to the primary completion date, 10 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Failure to complete the stress test due to reasons unrelated to cardiac conditions;
  • Post-enrollment development of conditions or identification of pathologies listed in the exclusion criteria.

Other

  • Poor recording quality of single-channel electrocardiogram (ECG) and/or plethysmography data;
  • Voluntary withdrawal of consent to continue participation in the study;

Who the study is looking for

  • 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.

Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.