COMA.NET: Targeted treatment for coronary microcirculation problems
Assessment of Risk Factors for Coronary Circulatory and Microcirculatory Disorders, Comparison of Invasive and Non-Invasive Diagnostic Methods, and Evaluation of the Impact of Individualized Pharmacotherapy Optimization on Patients' Quality of Life
This trial will test whether tailoring medicines based on intracoronary microvascular testing improves quality of life for people with ischemia but no large artery blockages.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medical University of Bialystok Academic / other |
| Locations | 1 site (Bialystok) |
| Trial ID | NCT07498231 on ClinicalTrials.gov |
What this trial studies
COMA.NET is a prospective, randomized, open-label, parallel-group trial enrolling about 180–190 participants with objective myocardial ischemia and non-obstructive coronary arteries. Participants are randomized to standard care or to endotype-guided pharmacotherapy based on invasive intracoronary microvascular assessment. The primary outcome is change in the Seattle Angina Questionnaire (SAQ) score from baseline to 3 months, with secondary outcomes including diagnostic accuracy of transthoracic CFVR, adverse event rates, biomarker associations with coronary microvascular dysfunction, and identification of risk factors for specific CMD endotypes. The trial tests whether identifying the specific CMD endotype and tailoring therapy accordingly produces greater symptom and quality-of-life benefit than usual care.
Who should consider this trial
Good fit: Ideal candidates are adults with chronic coronary syndrome who have anginal symptoms (CCS > I or angina equivalents) and objective ischemia on non-invasive testing, no obstructive coronary stenosis, and meet safety criteria such as eGFR ≥30 ml/min/1.73 m² and LVEF ≥40%.
Not a fit: Patients with angiographically significant coronary stenosis or FFR <0.8, recent acute coronary syndrome or recent PCI, prior CABG, severe LV dysfunction, active malignancy, type 1 diabetes, or coronary anatomy that prevents intracoronary assessment are unlikely to benefit from the endotype-guided approach.
Why it matters
Potential benefit: If successful, targeted, endotype-specific drug therapy could deliver larger and quicker improvements in angina symptoms and quality of life for people with INOCA/ANOCA.
How similar studies have performed: ESC guidelines support invasive functional testing and observational data and physiological studies support endotype-guided therapy, but randomized evidence is still limited and this trial seeks to fill that gap.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bialystok
- 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)
Study contacts
- Principal investigator: Sławomir Dobrzycki, MD, PhD — Medical University of Bialystok
- Study coordinator: Maciej A. Poludniewski, MD, PhD
- Email: maciej.poludniewski@umb.edu.pl
- Phone: +48 85-831-84-96
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.