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Clinical Trials in Poland / NCT07498231
Recruiting Not applicable

COronoary Microcirculation Analysis NETwork

NCT07498231 · tracked via the Priya Life Science Poland tracker
Sponsor
Medical University of Bialystok
Phase
Not applicable
Started
2025-10-10
Last updated
2026-04-08

Condition(s) studied

Coronary Artery DiseaseMicrocirculation ResistanceMicrocirculation; Biomarkers; Myocardial IschemiaMicrocirculatory DysfunctionMicrocirculatory StatusEchocardiographyDoppler Echocardiography

Investigational drug(s) / intervention(s)

Coronary microvascular function assessmentCoronary microvascular function assessment

Coronary microvascular function assessment: Comprehensive invasive and non-invasive evaluation of coronary microvascular function used to determine microvascular dysfunction endotype and guide treatment selection.

Coronary microvascular function assessment: Comprehensive invasive and non-invasive evaluation of coronary microvascular function used to determine microvascular dysfunction endotype without endotype-guided management.

Study summary

COMA.NET (Coronary Microcirculation Analysis Network) is a prospective, randomized, open-label, parallel-group clinical trial designed to determine whether endotype-guided pharmacotherapy is superior to standard care in improving quality of life in patients with ischemia with non-obstructive coronary arteries. Approximately 180-190 participants with objective ischemia will be randomized to either the control or the intervention group.

Pharmacotherapy based on the endotype established during intracoronary assessment will be introduced in the intervention arm of the study. The primary endpoint is the change in the Seattle Angina Questionnaire (SAQ) score from baseline to 3 months. Secondary endpoints include the diagnostic accuracy of transthoracic echocardiographic coronary flow velocity reserve (CFVR), the incidence of adverse events, associations between biomarkers and coronary microvascular dysfunction (CMD), and the identification of risk factors for specific CMD endotypes.

Participants will undergo invasive functional evaluation of the coronary microcirculation, measurement of echocardiographic CFVR, and analysis of selected circulating biomarkers. The study cohort will be followed up at three and six months and will include reassessment of quality of life (Seattle Angina Questionnaire, EuroQol 5-Dimensions 5-Level questionnaire, 12-item Short Form Health Survey), anxiety (Generalized Anxiety Disorder-7 score), and functional status (6-minute walk test).

The study began in October 2025. Primary completion is anticipated in October 2027, and the overall study completion date is expected in March 2028.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: a. Chronic coronary syndrome c. Anginal symptoms \> CCS class I or angina equivalent d. Myocardial ischemia confirmed by non-invasive testing e. Provision of informed consent to participate in the study Exclusion Criteria: 1. Angiographically significant coronary artery stenosis or FFR \< 0.8 2. Renal insufficiency with eGFR \< 30 ml/min/1.73 m² 3. Left ventricular ejection fraction \< 40% 4. Hypertrophic cardiomyopathy 5. Acute coronary syndrome within \< 90 days 6. Percutaneous coronary intervention (PCI) within \< 90 days 7. Previous coronary artery bypass grafting (CABG) 8. Anemia \< 10 g/dL or thrombocytopenia \< 100,000/µL 9. Intraventricular conduction disturbances preventing ST-T segment assessment 10. Severe concomitant valvular heart disease 11. Active malignancy 12. Type 1 diabetes mellitus 13. Coronary artery anatomical abnormalities precluding assessment using PressureWire X (myocardial bridge causing \> 50% luminal narrowing of the investigated vessel, severe coronary tortuosity, inability to properly cannulate coronary ostia) 14. Pregnancy 15. Heart failure ≥ NYHA class III 16. Asthma or COPD with severe irreversible airflow obstruction 17. Atrial fibrillation 18. Second- or third-degree atrioventricular block without pacemaker implantation (IPG) 19. Manifest pre-excitation on ECG or history of AVRT episodes without prior ablation of the accessory pathway

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Clinical Hospital, Department of Invasive Cardiology, Internal Medicine with CICU and Catheterization Laboratory-Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Kardiologii Inwazyjnej, Chorób Wewnętrznych z OIOK i Pracownią Hemodynamiki Bialystok Poland Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07498231 on ClinicalTrials.gov ↗ ← All trials in Poland