Breathomics and Single Channel Electrocardiogram in Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title: Biomarkers of the Exhaled Breath and Single-channel Electrocardiography in the Diagnosis of Myocardial Ischemia

Status Recruiting

Clinical Trial Summary

This is a prospective case-control single center observational non-randomized study. It is carried out to evaluate the diagnostic accuracy of functional tests with physical load under the control of a 12-channel ECG together with analysis of the parameters of volatile organic compounds of the exhaled breath, and single-channel ECG data.

Clinical Trial Description

The planned number of participants to include in the study is 60, admitted to the University Clinical Hospitals No. 1, at the I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University).

The study includes the following stages:

1. Participants will be selected according to inclusion and exclusion criteria;

2. Work with medical documentation;

3. Instrumental and laboratory examinations of the participants:

3.1. Analysis of exhaled air will be carried out with the Compact PTR-MS instrument manufactured by Ionicon (Austria) (analytical device), registration certificate No. (C16)07/C05.

3.2. Cardio ankle vascular index (CAVI) analysis will be conducted before the physical exertion, using the Fukuda Denshi apparatus (Japan), a microphone for cardio-phonogram measurements fixed with double-sided tape over the sternum in the second intercostal space.

3.3. All the participants will undergo a single blood sampling, during the day of performing of the study, blood test: 10 ml from a peripheral vein to determine the level of total cholesterol, low-density lipoprotein (LDL), very low-density lipoprotein (VLDL), high-density lipoprotein (HDL), Chylomicron, triglycerides, C-reactive protein (CRP), lipoprotein A little, apolipoprotein B, interleukin-6 (IL-6), interleukin-3 beta (IL-3 beta).

3.5. Both groups will perform a bicycle ergometry (on SCHILLER device) test to evaluate the response to physical activity.

3.6. Before and immediately after the exercise test, all patients are scheduled to record a single-channel ECG and pulse wave, using a portable single-channel recorder (Cardio-Qvark) (Russia, Moscow). ECG and pulse wave results will be interpreted using machine learning models.

4.6. Computed tomography myocardial perfusion imaging on a CT with 640 slices (Canon) during stress with Adenosine triphosphate will be performed.

After completion of the instrumental and laboratory analysis, a statistical analysis will be conducted. ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT06181799
• Study type: Observational
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Philipp Kopylov, Professor
• Phone: +7 (903) 687 72 64
• Email: kopylov_f_yu@staff.sechenov.ru
• Status: Recruiting
• Start date: November 1, 2023
• Completion date: June 30, 2026