NCT07498231 COronoary Microcirculation Analysis NETwork
| NCT ID | NCT07498231 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Bialystok |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-10-10 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2025-10-10 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Sławomir Dobrzycki, MD, PhD
PRINCIPAL INVESTIGATOR
Medical University of Bialystok
Frequently Asked Questions
Who can join the NCT07498231 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07498231 currently recruiting?
Yes, NCT07498231 is actively recruiting participants. Contact the research team at maciej.poludniewski@umb.edu.pl for enrollment information.
Where is the NCT07498231 trial being conducted?
This trial is being conducted at Bialystok, Poland.
Who is sponsoring the NCT07498231 clinical trial?
NCT07498231 is sponsored by Medical University of Bialystok. The principal investigator is Sławomir Dobrzycki, MD, PhD at Medical University of Bialystok. The trial plans to enroll 180 participants.