NCT07498231Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 23 Mar 2026
- Start date
- 10 Oct 2025
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Medical University of Bialystok
- Diseases
- Coronary artery disease
- NCT number
- NCT07498231
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 10 Oct 2025 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous coronary artery bypass grafting (CABG)
- Severe concomitant valvular heart disease
- Manifest pre-excitation on ECG or history of AVRT episodes without prior ablation of the accessory pathway
Other illness
- Acute coronary syndrome within \< 90 days
- Active malignancy
- Type 1 diabetes mellitus
- Coronary artery anatomical abnormalities precluding assessment using PressureWire X (myocardial bridge causing \> 50% luminal narrowing of the investigated vessel, severe coronary tortuosity, inability to properly cannulate coronary ostia)
- Heart failure ≥ NYHA class III
Lab values
- Renal insufficiency with eGFR \< 30 ml/min/1.73 m²
- Left ventricular ejection fraction \< 40%
- Anemia \< 10 g/dL or thrombocytopenia \< 100,000/µL
Other
- Angiographically significant coronary artery stenosis or FFR \< 0.8
- Hypertrophic cardiomyopathy
- Percutaneous coronary intervention (PCI) within \< 90 days
- Intraventricular conduction disturbances preventing ST-T segment assessment
- Pregnancy
- Asthma or COPD with severe irreversible airflow obstruction
- Atrial fibrillation
- Second- or third-degree atrioventricular block without pacemaker implantation (IPG)
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 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 Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.