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.
None
Angiographically significant coronary artery stenosis or FFR < 0.8
Renal insufficiency with eGFR < 30 ml/min/1.73 m²
Left ventricular ejection fraction < 40%
Hypertrophic cardiomyopathy
Parallel
Coronary microvascular function assessment
Diagnostic testComprehensive invasive and non-invasive evaluation of coronary microvascular function used to determine microvascular dysfunction endotype and guide treatment selection.
Coronary microvascular function assessment
Diagnostic testComprehensive invasive and non-invasive evaluation of coronary microvascular function used to determine microvascular dysfunction endotype without endotype-guided management.
Effectiveness of endotype-guided pharmacotherapy for coronary microvascular dysfunction
Comparison of the effectiveness of targeted pharmacotherapy tailored to the specific endotype of coronary microvascular dysfunction versus standard guideline-based pharmacotherapy. Assessment of changes in angina-related health status over time between study groups using the Seattle Angina Questionnaire (SAQ) ranging from 0 to 100, with higher scores indicating better health status and less angina-related limitations.
Prognostic value of selected blood and urinary biomarkers
Assessment whether selected biochemical markers measured in blood and urine are associated with the presence and severity of coronary microvascular dysfunction and whether they provide incremental prognostic information.
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index score
Assessment of changes in health-related quality of life including mobility, self-care, usual activities, pain/discomfort and anxiety/depression, ranging from -0.590 to 1.000 (based on values set for Polish population), with higher scores value indicating better health status, evaluated before and after targeted pharmacotherapy.
Diagnostic value of echocardiographic coronary velocity flow reserve (CFVR) assessment
Assessment of the diagnostic performance of echocardiographically measured coronary flow velocity reserve in detecting coronary microvascular dysfunction, compared with invasive coronary function testing as the reference standard.
12-item Short Form health survey (SF-12) score
Assessment of changes in health-related quality of life reflecting physical and mental health status, ranging from 0 to 100, with higher scores indicating better health status, evaluated before and after targeted pharmacotherapy.
Risk factors for specific endotypes of coronary microvascular dysfunction
To identify clinical, demographic, and biochemical factors associated with the occurrence of individual endotypes of coronary microvascular dysfunction.
Prevalence of coronary microvascular dysfunction endotypes in the Polish population
Determination of the frequency of individual endotypes of coronary microvascular dysfunction in the studied Polish population and to describe their clinical characteristics.
Adverse events
Assessment of the incidence and severity of adverse events occurring during the study period, including those related to diagnostic procedures and pharmacotherapy.
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