RecruitingNot ApplicableNCT07498231

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


Sponsor

Medical University of Bialystok

Enrollment

180 participants

Start Date

Oct 10, 2025

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Coronary microvascular function assessment and Coronary microvascular function assessment for people with coronary artery disease, doppler echocardiography, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCoronary microvascular function assessment

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

DIAGNOSTIC_TESTCoronary 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

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NCT07498231


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