Clinical trial NCT06181799: Breathome and Single Lead Electrocardiogram Optimizes Ischemic Heart Disease Diagnosis
Official title: Biomarkers of the Exhaled Breath and Single-Lead Electrocardiography in the Diagnosis of Myocardial Ischemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Keywords: Coronary Artery Disease
Mass Spectrometry
Volatilome
Single Lead-ECG
Ischemic Heart Disease
Lipidome
Inflammasome
Electrocardiography
Proton Transfer Reaction-Time Of Flight- Mass Spectrometer-1000 (PTR-TOF-MS-1000)
Stress Induced Myocardial Perfusion Defect
Qardio-Qvark
Stable Coronary Artery Disease
Angina Pectoris
Atherosclerosis
Breathome
Volatile Organic Compound
Bicycle Ergometry
Prevention
SCORE2
SCORE2-OP
Smart Risk Score
Machine Learning Model
Artificial intelligence
Cardiovascular disease
Risk Factor
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 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.
measure: 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.
timeFrame: 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.
measure: 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.
timeFrame: 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.
measure: Changes in the concentration of lipidome and inflammasome in individuals with coronary artery disease and individuals without coronary artery disease.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: 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
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University (Sechenov University)
name: Philipp Kopylov, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marzoog B. Breathomics Detect the Cardiovascular Disease: Delusion or Dilution of the Metabolomic Signature. Curr Cardiol Rev. 2024;20(4):e020224226647. doi: 10.2174/011573403X283768240124065853.
citation: Marzoog BA, Abdullaev M, Suvorov A, Chomakhidze P, Gognieva D, Gagarina NV, et al. Single Channel Electrocardiography Optimizes the Diagnostic Accuracy of Bicycle Ergometry! MedRxiv 2024:2024.04.20.24306122. https://doi.org/10.1101/2024.04.20.24306122.
citation: Marzoog BA, Gognieva D, Chomakhidze P, Kopylov P. Cardi-Ankle Vascular Index Optimizes Ischemic Heart disease Diagnosis. MedRxiv 2024:2024.07.03.24309877. https://doi.org/10.1101/2024.07.03.24309877.
citation: Marzoog BA, Chomakhidze P, Kopylov P. Reevaluation of the Bicycle Ergometry in the Diagnosis of Ischemic Heart Disease. MedRxiv 2024:2024.07.03.24309879. https://doi.org/10.1101/2024.07.03.24309879.
citation: Marzoog BA. Volatilome: A Novel Tool for Risk Scoring in Ischemic Heart Disease. Curr Cardiol Rev. 2024;20(6):e080724231719. doi: 10.2174/011573403X304090240705063536.
citation: B.A. Marzoog, P. Chomakhidze, A. Suvorov, P. Kopylov, CARDIO-QVARK Diagnose Ischemic Myocardiocyte!, (n.d.). https://doi.org/10.1101/2024.07.16.24310485.
citation: Marzoog BA, Chomakhidze P, Gognieva D, Gagarina NV, Silantyev A, Suvorov A, Fominykha E, Mustafina M, Natalya E, Gadzhiakhmedova A, Kopylov P. Machine Learning Model Discriminate Ischemic Heart Disease Using Breathome Analysis. Biomedicines. 2024 Dec 11;12(12):2814. doi: 10.3390/biomedicines12122814.
citation: Marzoog BA. Volatilome is Inflammasome- and Lipidome-dependent in Ischemic Heart Disease. Curr Cardiol Rev. 2024;20(6):e190724232038. doi: 10.2174/011573403X302934240715113647.