COronoary Microcirculation Analysis NETwork

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.

Conditions

• Coronary Artery Disease
• Microcirculation Resistance
• Microcirculation; Biomarkers; Myocardial Ischemia
• Microcirculatory Dysfunction
• Microcirculatory Status
• Echocardiography
• Doppler Echocardiography

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.

Sponsors & Collaborators

• Medical University of Bialystok

  lead OTHER

Principal Investigators

• Sławomir Dobrzycki, MD, PhD · Medical University of Bialystok

• Maciej A. Południewski, MD, PhD · Medical University of Bialystok

• Emil J. Dąbrowski, MD, PhD · Medical University of Białystok

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-10

Primary Completion

2027-10-31

Completion

2028-03-31

Countries

• Poland

Study Locations