At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Biomarkers of the Exhaled Breath and Single-Lead Electrocardiography in the Diagnosis of Myocardial Ischemia
In Brief
An observational study evaluating Mass spectrometry using the PTR TOF-1000 (IONICON PTR-TOF-MS - Trace VOC Analyzer, Eduard-Bodem-Gasse 3, 6020 Innsbruck, Austria (Europe). for Coronary Artery Disease and 4 related conditions. Completed, enrolled 80 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Once enrolled in the study, all participants are scheduled to undergo the following tests: Analysis of the exhaled breath volatile organic compounds using real-time analytical methods (PTR-TOF-MS-1000; real-time mass spectrometer with ionization by the proton transfer method) before and after the physical exertion test, during 1 minute. Machine learning models will be employed to analyze the patterns identified in the exhaled air volatilome data. Before and immediately after the physical exertion test, all participants are scheduled to record a single-lead ECG and pulse wave for 3 minutes, using a portable single-lead recorder (Cardio-Qvark) (Russia, Moscow). Single-lead ECG and pulse wave parameters will be analyzed using machine learning models.