COronoary Microcirculation Analysis NETwork

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 control or the intervention group. Pharmacotherapy based on endotype established during intracoronary assessment, will be introduced in the intervention arm of the study. The primary endpoint is the change in Seattle Angina Questionnaire (SAQ) score from baseline to 3 months. Secondary endpoints include diagnostic accuracy of transthoracic echocardiographic coronary flow velocity reserve (CFVR), incidence of adverse events, associations between biomarkers and CMD, and distinguishing of risk factors for specific CMD endotypes. Participants will be subjected to 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 (SAQ, EQ-5D-5L, SF-12), anxiety (GAD-7), and functional status (6-minute walk test). The study began in October 2025. Primary completion is anticipated in October 2027 and overall study completion date is expected in March 2028.

Eligibility

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

Conditions8

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