COronoary Microcirculation Analysis NETwork

NCT07498231 | Recruiting

• 1 other identifier: APK.002.133.2025
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

coma.net; coma-net; coronary microcirculation; ANOCA; INOCA; angina with non-obstructive coronary arteries; ischemia with non-obstructive coronary arteries

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed at baseline and at 3 months follow-up

Secondary Outcomes (6)

• Prognostic value of selected blood and urinary biomarkers

  12 months

• EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index score

  Assessed at baseline, after 3 and 6 months

• Diagnostic value of echocardiographic coronary velocity flow reserve (CFVR) assessment

  12 months

• 12-item Short Form health survey (SF-12) score

  Assessed at baseline, after 3 and 6 months

• Generalized Anxiety Disorder-7 (GAD-7) score

  Assessed at baseline, after 3 and 6 months

Other Outcomes (3)

• Risk factors for specific endotypes of coronary microvascular dysfunction

  12 months

• Prevalence of coronary microvascular dysfunction endotypes in the Polish population

  12 months

• Adverse events

  3 months

Study Arms (2)

Endotype-Guided Treatment Group

EXPERIMENTAL

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.

Diagnostic Test: Coronary microvascular function assessment

Standard Care Group

ACTIVE COMPARATOR

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.

Diagnostic Test: Coronary microvascular function assessment

Interventions

Coronary microvascular function assessment DIAGNOSTIC_TEST

Comprehensive invasive and non-invasive evaluation of coronary microvascular function used to determine microvascular dysfunction endotype and guide treatment selection.

Also known as: Endotype-guided management

Endotype-Guided Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Acute coronary syndrome within \< 90 days
• Percutaneous coronary intervention (PCI) within \< 90 days
• Previous coronary artery bypass grafting (CABG)
• Anemia \< 10 g/dL or thrombocytopenia \< 100,000/µL
• Intraventricular conduction disturbances preventing ST-T segment assessment
• Severe concomitant valvular heart disease
• 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)
• Pregnancy
• Heart failure ≥ NYHA class III

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (1)

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

Bialystok, 15-276, Poland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Sławomir Dobrzycki, MD, PhD

  Medical University of Bialystok

  PRINCIPAL INVESTIGATOR

• Maciej A. Południewski, MD, PhD

  Medical University of Bialystok

  STUDY CHAIR

• Emil J. Dąbrowski, MD, PhD

  Medical University of Białystok

  STUDY CHAIR

Central Study Contacts

Maciej A. Poludniewski, MD, PhD

CONTACT

+48 85-831-84-96; maciej.poludniewski@umb.edu.pl

Emil J. Dąbrowski, MD, PhD

CONTACT

+48 85-831-84-96; emil.dabrowski@umb.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: October 10, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)