COMA.NET: Targeted treatment for coronary microcirculation problems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.