N/A
Completed N=80
Volatilome and Single-Lead Electrocardiogram Optimize Ischemic Heart Disease Diagnosis Using Machine Learning Models
Coronary Artery Disease · Heart Failure · Angina Pectoris · Stable Coronary Artery Disease CAD
Source: ClinicalTrials.gov NCT06181799 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Diagnostic Accuracy (AUC, Sensitivity, Specificity, NPV, PPV) of the Stress-ECG Test in Ischemic Heart Disease — 0.507; 0.507; 0.484; 0.484 Proportion probability
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 via a 12-lead ECG, combined with analysis of exhaled breath volatile organic compounds (VOCs) and single-lead ECG parameters.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Accuracy (AUC, Sensitivity, Specificity, NPV, PPV) of the Stress-ECG Test in Ischemic Heart Disease |
0.507; 0.507; 0.484; 0.484; 0.531; 0.531 | — |
| PRIMARY Diagnostic Accuracy (AUC, Sensitivity, Specificity, NPV, PPV) of Exhaled Breath Analysis for Ischemic Heart Disease |
0.838; 0.838; 0.839; 0.839; 0.776; 0.776 | — |
| PRIMARY Diagnostic Accuracy (AUC, Sensitivity, Specificity, NPV, PPV) of Single-Lead ECG With Pulse Wave Analysis in Ischemic Heart Disease |
0.67; 0.67; 0.516; 0.516; 0.755; 0.755 | — |
| PRIMARY Changes in the Concentration of Total Cholesterol, TG (mmol/L), LDL (mmol/L), LDL (mmol/L), HDL (mmol/L), and VLDL (mmol/L) in Individuals With Stress-induced Myocardial Perfusion Defect vs. Without. |
5.61; 5.49; 1.41; 1.16; 3.46; 3.27 | — |
| PRIMARY Changes in the Concentration of Apolipoprotein B (g/L) in Individuals With Stress-induced Myocardial Perfusion Defect vs. Without. |
1.19; 1.08 | — |
| PRIMARY Changes in the Concentration of Lipoprotein (а) (mg/L) and c-RP (mg/L) in Individuals With Stress-induced Myocardial Perfusion Defect vs. Without. |
213.22; 253.67; 3.81; 3.09 | — |
| PRIMARY Changes in the Concentration of IL- 6 (pg/mL) in Individuals With Stress-induced Myocardial Perfusion Defect vs. Without. |
0.88; 0.86 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06181799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.