Coronary Artery DiseaseNCT06181799

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

An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for: Coronary Artery Disease, Ischemic Heart Disease, Chronic Coronary Disease
What is being tested?: Mass spectrometry using the PTR TOF-1000 (IONICON PTR-TOF-MS - Trace VOC Analyzer, Eduard-Bodem-Gasse 3, 6020 Innsbruck, Austria (Europe).
How many people: 80 participants
Where: 1 siteRussia
Study dates: 1 Nov 2023to 10 Jun 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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).

Who may be able to join

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

Show all 22Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Russia1 site

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, 119992

Other trials in Russia

About this study

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

Read the 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:

Participants will be selected according to inclusion and exclusion criteria;
Work with medical documentation;
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.

Conditions: Coronary Artery Disease, Ischemic Heart Disease, Chronic Coronary Disease, Angina Pectoris, Stable Coronary Artery Disease CAD
Being tested: Mass spectrometry using the PTR TOF-1000 (IONICON PTR-TOF-MS - Trace VOC Analyzer, Eduard-Bodem-Gasse 3, 6020 Innsbruck, Austria (Europe).
Keywords: Coronary Artery Disease, Mass Spectrometry, Volatilome, Single Lead-ECG, Ischemic Heart Disease, Lipidome, Inflammasome, Electrocardiography, PTR-TOF-MS-1000, Stress Induced Myocardial Perfusion Defect, Qardio-Qvark, Stable Coronary Artery Disease, Atherosclerosis, Breathome, Volatile Organic Compound, Bicycle Ergometry, Prevention, SCORE2, SCORE2-OP, Smart Risk Score
Medical subject headings: Coronary Artery Disease, Myocardial Ischemia, Angina Pectoris, Atherosclerosis, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06181799
Study group	Role	What they receive
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)). Receives: Diagnostic Test: Mass spectrometry using the PTR TOF-1000 (IONICON PTR-TOF-MS - Trace VOC Analyzer, Eduard-Bodem-Gasse 3, 6020 Innsbruck, Austria (Europe).
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)). Receives: Diagnostic Test: Mass spectrometry using the PTR TOF-1000 (IONICON PTR-TOF-MS - Trace VOC Analyzer, Eduard-Bodem-Gasse 3, 6020 Innsbruck, Austria (Europe).

What is being measured

The primary outcome is the main question the study is designed to answer.

Diagnostic Accuracy (AUC, Sensitivity, Specificity, NPV, PPV) of the Stress-ECG Test in Ischemic Heart Disease
Assessing the diagnostic accuracy of the stress electrocardiography test in ischemic heart disease
Measured: 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
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
Measured: 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
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: The study was completed on 10.06.2024; the outcome measure was assessed during 1 week for the IL- 6 (pg/mL) data.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202310 Jun 2024

First posted26 Dec 2023
Study start1 Nov 2023
Primary completion10 Jun 2024
Study completion10 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06181799
Sponsor's protocol ID: 13011998
Status last verified: Oct 2023
First submitted: 13 Dec 2023
Last updated: 15 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No, due to the prohibition by the local ethical committee

Publications

Marzoog BA, Kopylov P. Volatilome and machine learning in ischemic heart disease: Current challenges and future perspectives. World J Cardiol. 2025 Apr 26;17(4):106593. doi: 10.4330/wjc.v17.i4.106593.
PubMed 40308617
Marzoog BA, Chomakhidze P, Gognieva D, Parunova AY, Demchuk SN, Silantyev A, Kuznetsova N, Kostikova A, Podgalo D, Nagornov E, Gadzhiakhmedova A, Kopylov P. Updates in breathomics behavior in ischemic heart disease and heart failure, mass-spectrometry. World J Cardiol. 2025 Feb 26;17(2):102851. doi: 10.4330/wjc.v17.i2.102851.
PubMed 40061284
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.
PubMed 38318837
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.
Marzoog BA. Volatilome: A Novel Tool for Risk Scoring in Ischemic Heart Disease. Curr Cardiol Rev. 2024;20(6):e080724231719. doi: 10.2174/011573403X304090240705063536.
PubMed 38982923
Marzoog BA. Volatilome is Inflammasome- and Lipidome-dependent in Ischemic Heart Disease. Curr Cardiol Rev. 2024;20(6):e190724232038. doi: 10.2174/011573403X302934240715113647.
PubMed 39039680
Marzoog BA, Chomakhidze P, Gognieva D, Silantyev A, Suvorov A, Abdullaev M, Mozzhukhina N, Filippova DA, Kostin SV, Kolpashnikova M, Ershova N, Ushakov N, Mesitskaya D, Kopylov P. Development and validation of a machine learning model for diagnosis of ischemic heart disease using single-lead electrocardiogram parameters. World J Cardiol. 2025 Apr 26;17(4):104396. doi: 10.4330/wjc.v17.i4.104396.
PubMed 40308623
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.
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.
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.
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.
PubMed 39767720
Marzoog BA, Chomakhidze P, Gognieva D, Silantyev A, Suvorov A, Stroeva A, Mustafina M, Fedorova AY, Syrkin A, Kopylov P. Exhaled Breath Biomarkers Reflect the Inflammasome and Lipidome Changes in Ischemic Heart Disease: A Study Using Machine Learning Models and Network Analysis. J Lipid Atheroscler. 2025 Sep;14(3):350-371. doi: 10.12997/jla.2025.14.3.350. Epub 2025 Jul 8.
PubMed 41048598

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Biomarkers of the Exhaled Breath and Single-Lead Electrocardiography in the Diagnosis of Myocardial Ischemia
ClinicalTrials.gov ID: NCT06181799
Acronym / sponsor ID: 13011998
Conditions: Coronary Artery Disease, Ischemic Heart Disease, Chronic Coronary Disease, Angina Pectoris, Stable Coronary Artery Disease CAD
Keywords: Coronary Artery Disease, Mass Spectrometry, Volatilome, Single Lead-ECG, Ischemic Heart Disease, Lipidome, Inflammasome, Electrocardiography
Study type: Observational
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
Study start: 1 Nov 2023 (actual)
Primary completion: 10 Jun 2024 (actual)
Study completion: 10 Jun 2024 (actual)
First posted: 26 Dec 2023 (actual)
Results: Posted 15 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study includes the following stages:

Participants will be selected according to inclusion and exclusion criteria;
Work with medical documentation;
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.

3.3. 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).

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 design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Experimental group	–	Diagnostic Test: 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	–	Diagnostic Test: 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)).

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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).

Key inclusion criteria (22 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Diagnostic test	Control group, Experimental group

Primary outcome

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
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
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.
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.
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.
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.
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.

Results and safety

Results posted to the registry on 15 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Group	31	31
Control Group	49	49

Primary outcome: 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. Number (95% Confidence Interval). Unit: Proportion probability

Measure	Experimental Group n = 31	Control Group n = 49
AUC	0.507 (0.388 to 0.625)	0.507 (0.388 to 0.625)
Sensitivity	0.484 (0.306 to 0.657)	0.484 (0.306 to 0.657)
Specificity	0.531 (0.392 to 0.673)	0.531 (0.392 to 0.673)
NPV NPV NPV NPV	0.619 (0.465 to 0.758)	0.619 (0.465 to 0.758)
PPV	0.395 (0.238 to 0.553)	0.395 (0.238 to 0.553)

Primary outcome: 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.. Number (95% Confidence Interval). Unit: Proportion probability

Measure	Experimental Group n = 31	Control Group n = 49
AUC	0.838 (0.736 to 0.914)	0.838 (0.736 to 0.914)
Sensitivity	0.839 (0.692 to 0.964)	0.839 (0.692 to 0.964)
Specificity	0.776 (0.666 to 0.889)	0.776 (0.666 to 0.889)
NPV	0.884 (0.771 to 0.975)	0.884 (0.771 to 0.975)
PPV	0.703 (0.559 to 0.849)	0.703 (0.559 to 0.849)

Primary outcome: 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. Number (95% Confidence Interval). Unit: Proportion probability

Measure	Experimental Group n = 31	Control Group n = 49
AUC	0.67 (0.530 to 0.801)	0.67 (0.530 to 0.801)
Sensitivity	0.516 (0.333 to 0.695)	0.516 (0.333 to 0.695)
Specificity	0.755 (0.628 to 0.880)	0.755 (0.628 to 0.880)
NPV	0.712 (0.586 to 0.830)	0.712 (0.586 to 0.830)
PPV	0.571 (0.387 to 0.758)	0.571 (0.387 to 0.758)

Primary outcome: 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.. Mean (Standard Deviation). Unit: mmol/L

Measure	Experimental Group n = 31	Control Group n = 49
Total cholesterol (mmol/L)	5.61 (1.56)	5.49 (1.43)
TG (mmol/L)	1.41 (0.77)	1.16 (0.54)
LDL (mmol/L)	3.46 (1.08)	3.27 (0.96)
HDL (mmol/L)	1.28 (0.34)	1.44 (0.50)
VLDL (mmol/L)	0.64 (0.35)	0.52 (0.25)

Adverse events

Time frame: Over 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Group	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Control Group	0 of 49 (0%)	0 of 49 (0%)	0 of 49

Limitations and caveats (from the sponsor): Breath analysis for CAD diagnosis has limitations: bulky/expensive spirometers need portable VOC-specific devices; small sample size requires larger validation trials for combined ECG-breath biomarkers; lack of standardized protocols/reference databases hinders reproducibility. Statistical bias was mitigated via resampling, normalization, and median statistics. Partial consistency with known physiological patterns supports validity despite constraints.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 40308617Marzoog BA, Kopylov P. Volatilome and machine learning in ischemic heart disease: Current challenges and future perspectives. World J Cardiol. 2025 Apr 26;17(4):106593. doi: 10.4330/wjc.v17.i4.106593.
Background: PubMed 40061284Marzoog BA, Chomakhidze P, Gognieva D, Parunova AY, Demchuk SN, Silantyev A, Kuznetsova N, Kostikova A, Podgalo D, Nagornov E, Gadzhiakhmedova A, Kopylov P. Updates in breathomics behavior in ischemic heart disease and heart failure, mass-spectrometry. World J Cardiol. 2025 Feb 26;17(2):102851. doi: 10.4330/wjc.v17.i2.102851.
Background: PubMed 38318837Marzoog B. Breathomics Detect the Cardiovascular Disease: Delusion or Dilution of the Metabolomic Signature. Curr Cardiol Rev. 2024;20(4):e020224226647. doi: 10.2174/011573403X283768240124065853.
BackgroundMarzoog 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.
Background: PubMed 38982923Marzoog BA. Volatilome: A Novel Tool for Risk Scoring in Ischemic Heart Disease. Curr Cardiol Rev. 2024;20(6):e080724231719. doi: 10.2174/011573403X304090240705063536.
Background: PubMed 39039680Marzoog BA. Volatilome is Inflammasome- and Lipidome-dependent in Ischemic Heart Disease. Curr Cardiol Rev. 2024;20(6):e190724232038. doi: 10.2174/011573403X302934240715113647.
Results publication: PubMed 40308623Marzoog BA, Chomakhidze P, Gognieva D, Silantyev A, Suvorov A, Abdullaev M, Mozzhukhina N, Filippova DA, Kostin SV, Kolpashnikova M, Ershova N, Ushakov N, Mesitskaya D, Kopylov P. Development and validation of a machine learning model for diagnosis of ischemic heart disease using single-lead electrocardiogram parameters. World J Cardiol. 2025 Apr 26;17(4):104396. doi: 10.4330/wjc.v17.i4.104396.
Results publicationMarzoog 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.
Results publicationMarzoog 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.
Results publicationB.A. Marzoog, P. Chomakhidze, A. Suvorov, P. Kopylov, CARDIO-QVARK Diagnose Ischemic Myocardiocyte!, (n.d.). https://doi.org/10.1101/2024.07.16.24310485.
Results publication: PubMed 39767720Marzoog 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.
Results publication: PubMed 41048598Marzoog BA, Chomakhidze P, Gognieva D, Silantyev A, Suvorov A, Stroeva A, Mustafina M, Fedorova AY, Syrkin A, Kopylov P. Exhaled Breath Biomarkers Reflect the Inflammasome and Lipidome Changes in Ischemic Heart Disease: A Study Using Machine Learning Models and Network Analysis. J Lipid Atheroscler. 2025 Sep;14(3):350-371. doi: 10.12997/jla.2025.14.3.350. Epub 2025 Jul 8.
Individual participant dataSharing planned: No. No, due to the prohibition by the local ethical committee

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philipp Kopylov, Professor principal investigator

I.M. Sechenov First Moscow State Medical University (Sechenov University)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06181799, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.