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

August 14, 2025 updated by: I.M. Sechenov First Moscow State Medical University

Biomarkers of the Exhaled Breath and Single-Lead Electrocardiography in the Diagnosis of Myocardial Ischemia

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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. All the participants will undergo a single blood sampling during the day of performing the study, a 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, and interleukin-6 (IL-6).

3.3. Both groups will perform a bicycle ergometry test (on a SCHILLER c200 device) to evaluate the response to physical activity.

3.4. 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).

4.5. Stress computed tomography myocardial perfusion imaging (CTP) with a vasodilation test using adenosine triphosphate on a CT device with 640 slices (Canon; Aquilion One Genesis) will be performed.

After completion of the instrumental and laboratory analysis, a statistical analysis will be conducted using classical statistics and machine learning methods, including gradient boosting.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 119992
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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).

Description

Inclusion Criteria:

  1. Age ≥40 years;
  2. Absence of acute exacerbations of psychiatric disorders or cognitive impairments that would preclude study participation;
  3. Provision of written informed consent for study participation, blood sample collection, and anonymous publication of research results;
  4. Pre-test probability of ischemic heart disease between 1% and 33%.

Non-inclusion criteria:

  1. Pregnancy and breastfeeding;
  2. Diabetes mellitus;
  3. Presence of acute myocardial ischemia (acute coronary syndrome or myocardial infarction within the preceding 48 hours) or a history of myocardial infarction;
  4. Active infectious or non-infectious inflammatory diseases in the acute/exacerbation phase;
  5. Connective tissue diseases (regardless of disease activity);
  6. Respiratory disorders (e.g., bronchial asthma, chronic bronchitis, cystic fibrosis, or other conditions associated with significant respiratory dysfunction);
  7. Acute pulmonary thromboembolism involving the pulmonary artery or its branches;
  8. Aortic dissection;
  9. Hemodynamically significant decompensated cardiac valvular defects**;
  10. Active malignancy;
  11. Decompensated chronic heart failure (NYHA class III-IV) or acute heart failure;
  12. Neurological disorders (e.g., Parkinson's disease, multiple sclerosis, acute psychosis, Guillain-Barré syndrome);
  13. Cardiac arrhythmias or conduction abnormalities contraindicating stress testing;
  14. Musculoskeletal disorders precluding exercise testing (e.g., bicycle ergometry);
  15. Allergy to radiocontrast agents and/or adenosine triphosphate (ATP);
  16. Chronic kidney disease with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² (CKD-EPI formula);
  17. Severe hepatic insufficiency and/or Child-Pugh class B or C liver cirrhosis.

Exclusion Criteria:

  1. Poor recording quality of single-channel electrocardiogram (ECG) and/or plethysmography data;
  2. Failure to complete the stress test due to reasons unrelated to cardiac conditions;
  3. Voluntary withdrawal of consent to continue participation in the study;
  4. Post-enrollment development of conditions or identification of pathologies listed in the exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental group
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)).
Diagnostic test: Mass spectrometry using the PTR TOF-1000 (IONICON PTR-TOF-MS - Trace VOC Analyzer, Eduard-Bodem-Gasse 3, 6020 Innsbruck, Austria (Europe).

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.
Control group
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)).
Diagnostic test: Mass spectrometry using the PTR TOF-1000 (IONICON PTR-TOF-MS - Trace VOC Analyzer, Eduard-Bodem-Gasse 3, 6020 Innsbruck, Austria (Europe).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy (AUC, Sensitivity, Specificity, NPV, PPV) of the Stress-ECG Test in Ischemic Heart Disease
Time Frame: The study was completed on 10.06.2024; the outcome measure was assessed during 6 months for the stress electrocardiography test
Assessing the diagnostic accuracy of the stress electrocardiography test in ischemic heart disease
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
Time Frame: The study was completed on 10.06.2024; the outcome measure was assessed during 6 months for the obtained volatilome data.
Analyze the volatile organic compounds of the exhaled breath in individuals with stress-induced myocardial perfusion defect on stress computed tomography myocardial perfusion imaging (CTP) with vasodilation test (adenosine triphosphate) and compare them with individuals without stress-induced myocardial perfusion defect after a physical stress test, and compare them with rest results as independent variables. Machine learning model was used to assess the diagnostic accuracy of the exhaled breath in the diagnosis of ischemic heart disease
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
Time Frame: 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
Analyze the parameters of the single-lead electrocardiogram with pulse wave function in individuals with stress-induced myocardial perfusion defect on stress computed tomography myocardial perfusion imaging (CTP) with vasodilation test and compare them with individuals without stress-induced myocardial perfusion defect as an independent variable. Machine learning model was used to assess the diagnostic accuracy of the single-lead ECG with pulse wave function in the diagnosis of ischemic heart disease.
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.
Time Frame: 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.
Analyzing the taken blood samples for 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 on stress computed tomography myocardial perfusion imaging (CTP) with vasodilation test and comparing them with individuals without stress-induced myocardial perfusion defect as independent variables.
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.
Time Frame: The study was completed on 10.06.2024; the outcome measure was assessed during 1 week for the Apolipoprotein В (g/L) data.
Analyzing the taken blood samples for Apolipoprotein B (g/L) in individuals with stress-induced myocardial perfusion defect on stress computed tomography myocardial perfusion imaging (CTP) with vasodilation test and comparing them with individuals without stress-induced myocardial perfusion defect as independent variables.
The study was completed on 10.06.2024; the outcome measure was assessed during 1 week for the Apolipoprotein В (g/L) data.
Changes in the Concentration of Lipoprotein (а) (mg/L) and c-RP (mg/L) in Individuals With Stress-induced Myocardial Perfusion Defect vs. Without.
Time Frame: The study was completed on 10.06.2024; the outcome measure was assessed during 1 week for the lipoprotein (а) (mg/L) and c-RP (mg/L) data.
Analyzing the taken blood samples for lipoprotein (a) (mg/L) and C-RP (mg/L) in individuals with stress-induced myocardial perfusion defect on stress computed tomography myocardial perfusion imaging (CTP) with vasodilation test and comparing them with individuals without stress-induced myocardial perfusion defect as independent variables.
The study was completed on 10.06.2024; the outcome measure was assessed during 1 week for the lipoprotein (а) (mg/L) and c-RP (mg/L) data.
Changes in the Concentration of IL- 6 (pg/mL) in Individuals With Stress-induced Myocardial Perfusion Defect vs. Without.
Time Frame: The study was completed on 10.06.2024; the outcome measure was assessed during 1 week for the IL- 6 (pg/mL) data.
Analyzing the taken blood samples for IL-6 (pg/mL) in individuals with stress-induced myocardial perfusion defect on stress computed tomography myocardial perfusion imaging (CTP) with vasodilation test and comparing them with individuals without stress-induced myocardial perfusion defect as independent variables.
The study was completed on 10.06.2024; the outcome measure was assessed during 1 week for the IL- 6 (pg/mL) data.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Investigators

  • Principal Investigator: Philipp Kopylov, Professor, I.M. Sechenov First Moscow State Medical University (Sechenov University)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

June 10, 2024

Study Completion (Actual)

June 10, 2024

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13011998

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No, due to the prohibition by the local ethical committee

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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