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RECRUITING
NCT07498231
NA

COronoary Microcirculation Analysis NETwork

Sponsor: Medical University of Bialystok

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-10-10

Completion Date

2028-03

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Coronary microvascular function assessment

Comprehensive invasive and non-invasive evaluation of coronary microvascular function used to determine microvascular dysfunction endotype and guide treatment selection.

DIAGNOSTIC_TEST

Coronary microvascular function assessment

Comprehensive invasive and non-invasive evaluation of coronary microvascular function used to determine microvascular dysfunction endotype without endotype-guided management.

Locations (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