Breathome and Single Lead Electrocardiogram Optimizes Ischemic Heart Disease Diagnosis

Completed

• Conditions: Ischemic Heart Disease; Coronary Artery Disease
• Interventions: Diagnostic Test: Mass spectrometry using the PTR TOF-1000 (IONICON PTR-TOF-MS - Trace VOC Analyzer, Eduard-Bodem-Gasse 3, 6020 Innsbruck, Austria (Europe).

• Registration Number: NCT06181799
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief 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-lead ECG together with analysis of the parameters of volatile organic compounds of the exhaled breath, and single-lead ECG data.

Detailed Description

The planned number of participants to include in the study is 80, 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), triglycerides, C-reactive protein (CRP), lipoprotein a, apolipoprotein B, interleukin-6 (IL-6), interleukin-3 (IL-3 ).

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-lead ECG and pulse wave, using a portable single-lead recorder (Cardio-Qvark) (Russia, Moscow).

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 using classical statistics and artificial intelligence as well as machine learning models.

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-11-01
• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2023-12-13
• Study First Posted: 2023-12-26
• Primary Completion: 2024-06-10
• Study Completion: 2024-06-10
• Last Update Submitted: 2024-07-27
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Participants age ≥ 40 years.
2. Patients with intact mental and physical activity.
3. Written consent to participate in the study, take blood tests, and anonymously publish the results of the study.
4. The participants of the control group are individuals without coronary artery disease, confirmed by the absence of the myocardial perfusion defect on the adenosine triphosphate stress myocardial perfusion computed tomography, and confirmed by medical history, previous medical tests, and retrospective interview of participants, and they will mainly be athletes.
5. The participants of the experimental group are individuals with coronary artery disease, confirmed by myocardial perfusion defect on the adenosine triphosphate stress myocardial perfusion computed tomography, and confirmed by medical history, previous medical tests, and retrospective interview of participants.

Non-inclusion criteria:

1. Pregnancy and breast feeding.
2. Presence of signs of acute coronary syndrome (myocardial infarction in the last two days), history of myocardial infarction;
3. Active infectious and non-infectious inflammatory diseases in the exacerbation phase;
4. Respiratory diseases (bronchial asthma, chronic bronchitis, cystic fibrosis);
5. Acute thromboembolism of pulmonary artery branches;
6. Aortic dissection;
7. Critical heart defects;
8. Active oncopathology;
9. Decompensation phase of acute heart failure or heart failure III-IV stage;
10. Neurological pathology (Parkinson's disease, multiple sclerosis, acute psychosis, Guillain-Barré syndrome);
11. Cardiac arrhythmias that do not allow exercise ECG testing (Wolff-Parkinson-White syndrome, Sick sinus syndrome, AV block of II-III-degree, persistent ventricular tachycardia);
12. Diseases of the musculoskeletal system that prevent passing a stress test (bicycle ergometry);
13. Allergic reaction to iodine.
14. Diabetes mellitus

Exclusion Criteria

1. Poor single-lead ECG and pulse wave recording quality
2. Failure of the stress test stop criterion
3. Reluctance to continue participating in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental group	Mass spectrometry using the PTR TOF-1000 (IONICON PTR-TOF-MS - Trace VOC Analyzer, Eduard-Bodem-Gasse 3, 6020 Innsbruck, Austria (Europe).	The group is planned to include 31 people with myocardial perfusion defect on the stress computed tomography myocardial perfusion Imaging (by using contrast enhanced multi-slice spiral computed tomography (CE-MSCT) using adenosine triphosphate (ATP)).
Control group	Mass spectrometry using the PTR TOF-1000 (IONICON PTR-TOF-MS - Trace VOC Analyzer, Eduard-Bodem-Gasse 3, 6020 Innsbruck, Austria (Europe).	The group is planned to include 49 people without myocardial perfusion defect on the stress computed tomography myocardial perfusion imaging (by using contrast enhanced multi-slice spiral computed tomography (CE-MSCT) using adenosine triphosphate (ATP)).

Primary Outcome Measures

Name	Time	Method
Changes in the concentration of several volatile organic compounds in the exhaled air before and after physical exertion will be detected, increasing the accuracy of the stress ECG test.	After the study is complete in March 2026, the data will be analyzed and interpreted. The primary outcomes are expected to be ready in September 2026.	By analysis the components of the exhaled air in individuals with myocardial perfusion defect on Stress Myocardial Perfusion Computed Tomography and compare them with individuals without myocardial perfusion defect after physical stress test and compare it with rest results, as independent and dependent variables.
The parameters of single-lead ECG and pulse wave, both at rest and after physical stress test, predicting the presence of significant coronary insufficiency, will be determined.	After the study is complete in March 2026, the data will be analyzed and interpreted. The primary outcomes are expected to be ready in September 2026.	By analysis the components of the single lead electrocardiography in individuals with myocardial perfusion defect on Adenosine Triphosphate Stress Myocardial Perfusion Computed Tomography and compare them with individuals without myocardial perfusion defect using machine learning models in interpretation of the primary electrocardiography and pulse wave data, as dependent and independent variables.
Changes in the concentration of several volatile organic compounds in exhaled air at rest, correlating with the presence or absence of coronary insufficiency, will be revealed.	After the study is complete in March 2026, the data will be analyzed and interpreted. The primary outcomes are expected to be ready in September 2026.	By analysis the components of the exhaled air in individuals with myocardial perfusion defect on Stress Myocardial Perfusion Computed Tomography and compare them with individuals without myocardial perfusion defect at rest, as independent and dependent variables.
Changes in the concentration of lipidome and inflammasome in individuals with coronary artery disease and individuals without coronary artery disease.	After the study is complete in March 2026, the data will be analyzed and interpreted. The primary outcomes are expected to be ready in September 2026.	By analysis of the taken blood samples for lipidome and inflammasome biomarkers in individuals with myocardial perfusion defect on Stress Myocardial Perfusion Computed Tomography and compare them with individuals without myocardial perfusion defect at rest, as independent variables.

Trial Locations

Locations (1)

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; 🇷🇺 Moscow, Russian Federation