Actively Recruiting
COronoary Microcirculation Analysis NETwork
Led by Medical University of Bialystok · Updated on 2026-04-08
180
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
COronoary Microcirculation Analysis NETwork
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with chronic coronary syndrome
- Anginal symptoms greater than CCS class I or equivalent chest pain
- Myocardial ischemia confirmed by non-invasive testing
- Provided informed consent to participate in the study
You will not qualify if you...
- Significant coronary artery stenosis or fractional flow reserve (FFR) below 0.8
- Renal insufficiency with eGFR below 30 ml/min/1.73 m²
- Left ventricular ejection fraction below 40%
- Hypertrophic cardiomyopathy
- Acute coronary syndrome within the past 90 days
- Percutaneous coronary intervention within the past 90 days
- Previous coronary artery bypass grafting
- Anemia below 10 g/dL or thrombocytopenia below 100,000/µL
- Intraventricular conduction disturbances preventing ST-T segment assessment
- Severe valvular heart disease
- Active malignancy
- Type 1 diabetes mellitus
- Coronary artery abnormalities preventing PressureWire X assessment
- Pregnancy
- Heart failure class III or higher
- Severe asthma or COPD with irreversible airway obstruction
- Atrial fibrillation
- Second- or third-degree atrioventricular block without pacemaker
- Pre-excitation on ECG or history of AVRT without prior ablation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
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, 15-276
Actively Recruiting
Research Team
M
Maciej A. Poludniewski, MD, PhD
CONTACT
E
Emil J. Dąbrowski, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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