COronoary Microcirculation Analysis NETwork

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease, Microcirculation Resistance, Microcirculation; Biomarkers; Myocardial Ischemia, Microcirculatory Dysfunction, Microcirculatory Status, Echocardiography, Doppler Echocardiography

In brief

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.

Key facts

Study ID: NCT07498231
Run by: Medical University of Bialystok
People needed: 180
Starts: 2025-10-10
Expected to finish: 2028-03-01
Last updated by the study team: 2026-04-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Angiographically significant coronary artery stenosis or FFR < 0.8
Renal insufficiency with eGFR < 30 ml/min/1.73 m²
Left ventricular ejection fraction < 40%
Hypertrophic cardiomyopathy
Acute coronary syndrome within < 90 days
Percutaneous coronary intervention (PCI) within < 90 days
Previous coronary artery bypass grafting (CABG)
Anemia < 10 g/dL or thrombocytopenia < 100,000/µL
Intraventricular conduction disturbances preventing ST-T segment assessment
Severe concomitant valvular heart disease
Active malignancy
Type 1 diabetes mellitus
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)
Pregnancy
Heart failure ≥ NYHA class III
Asthma or COPD with severe irreversible airflow obstruction
Atrial fibrillation
Second- or third-degree atrioventricular block without pacemaker implantation (IPG)
Manifest pre-excitation on ECG or history of AVRT episodes without prior ablation of the accessory pathway

Where it is 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 (enrolling)

Full record on ClinicalTrials.gov

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