CompletedNot Applicable

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

Russia80 participantsStarted 2023-11-01

Plain-language 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.

Who can participate

Age range40 Years

SexALL

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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%.
✓. 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;

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.

What they're measuring

Diagnostic Accuracy (AUC, Sensitivity, Specificity, NPV, PPV) of the Stress-ECG Test in Ischemic Heart Disease

Timeframe: The study was completed on 10.06.2024; the outcome measure was assessed during 6 months for the stress electrocardiography test

Diagnostic Accuracy (AUC, Sensitivity, Specificity, NPV, PPV) of Exhaled Breath Analysis for Ischemic Heart Disease

Timeframe: The study was completed on 10.06.2024; the outcome measure was assessed during 6 months for the obtained volatilome data.

Diagnostic Accuracy (AUC, Sensitivity, Specificity, NPV, PPV) of Single-Lead ECG With Pulse Wave Analysis in Ischemic Heart Disease

Timeframe: The study was completed on 10.06.2024; the outcome measure was assessed during 6 months for the single lead ECG parameters with pulse wave function

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.

Timeframe: The study was completed on 10.06.2024; the outcome measure was assessed during 1 week for the total cholesterol, TG (mmol/L), LDL (mmol/L), LDL (mmol/L), HDL (mmol/L), and VLDL (mmol/L) data.

Changes in the Concentration of Apolipoprotein B (g/L) in Individuals With Stress-induced Myocardial Perfusion Defect vs. Without.

Timeframe: The study was completed on 10.06.2024; the outcome measure was assessed during 1 week for the Apolipoprotein В (g/L) data.

Trial details

NCT IDNCT06181799

SponsorI.M. Sechenov First Moscow State Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-10

Results submitted2025-05-12

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