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COronoary Microcirculation Analysis NETwork

Study acronym: COMA-NET
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Secondary endpoints: details revised at 1 of 6 entriesv3
  2. Secondary endpoints: details revised at 3 of 6 entries
    • Study description expanded, about 15 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07498231
Lead Sponsor Medical University of Bialystok
Conditions
(from sponsor)		 Coronary Artery Disease, Microcirculation Resistance, Microcirculation; Biomarkers; Myocardial Ischemia, Microcirculatory Dysfunction, Microcirculatory Status, Echocardiography, Doppler Echocardiography
Related terms Coronary Artery Disease, Myocardial Ischemia
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov