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COronoary Microcirculation Analysis NETwork

RecruitingNAAges 18 Years - 75 YearsAllMedical University of Bialystok
NCT07498231 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 microva

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📋 Eligibility rules (as published)
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
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What it tests

  • Coronary microvascular function assessment
  • Coronary microvascular function assessment
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Where

1 site
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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