COronoary Microcirculation Analysis NETwork
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
Medical University of Bialystok
180 participants
Oct 10, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- 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 Criteria19
- 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
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Interventions
Comprehensive invasive and non-invasive evaluation of coronary microvascular function used to determine microvascular dysfunction endotype and guide treatment selection.
Comprehensive invasive and non-invasive evaluation of coronary microvascular function used to determine microvascular dysfunction endotype without endotype-guided management.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07498231