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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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Poland
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
RECRUITING
Bialystok
Contact Information
Primary
Maciej A. Poludniewski, MD, PhD
maciej.poludniewski@umb.edu.pl
+48 85-831-84-96
Backup
Emil J. Dąbrowski, MD, PhD
emil.dabrowski@umb.edu.pl
+48 85-831-84-96
Time Frame
Start Date: 2025-10-10
Estimated Completion Date: 2028-03
Participants
Target number of participants: 180
Treatments
Experimental: Endotype-Guided Treatment Group
Participants undergo invasive and non-invasive assessment of coronary microvascular function to determine the INOCA endotype. The invasive assessment includes intracoronary acetylcholine provocation testing followed by guidewire-based measurement of coronary flow reserve and index of microvascular resistance during pharmacologically induced hyperemia. Non-invasive assessment includes echocardiographic coronary flow velocity reserve measurement in the left anterior descending artery.~Based on the identified endotype of coronary microvascular dysfunction, participants receive guideline-directed pharmacotherapy targeted to the underlying mechanism in accordance with contemporary European Society of Cardiology recommendations. Follow-up assessments include quality-of-life questionnaires, functional capacity testing, and laboratory evaluation.
Active_comparator: Standard Care Group
Participants undergo the same invasive and non-invasive assessment of coronary microvascular function. Pharmacotherapy is determined by the treating physician according to standard clinical practice, without protocol-mandated endotype-guided treatment selection.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Bialystok

This content was sourced from clinicaltrials.gov