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Active, not recruiting Observational

The Euro-CRAFT Registry

NCT05805462 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2022-09-22
Last updated
2026-01-12

Condition(s) studied

Coronary Microvascular Disease

Study summary

The Euro-CRAFT Registry is a prospective, multicentric, international registry of patients undergoing functional assessment of the coronary microcirculation using the continuous thermodilution technique. Angina and quality of life questionnaires (Seattle Angina Questionnaire 19 - SAQ19, ORBITA app) will be obtained at baseline, at 6 months, and 1-year follow-up. Clinical follow-up will be performed at 1 year (optionally until 5 years).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age \> 18 years. * Stable patients should have complaints of chest pain suspected of angina pectoris or other symptoms raising the suspicion of IHD and non-obstructive epicardial coronary arteries on invasive coronary angiography (ICA, diameter stenosis of less than 50%) with an FFR \>0.80. * Any other clinical scenario (including in the context of ACS) prompting the physician to assess the function of the coronary microvasculature. Exclusion Criteria: * Unable to provide consent * Unstable hemodynamics * Ongoing chest pain. * Previous CABG * Moderate to severe valvular heart disease * Uncontrolled or recurrent ventricular tachycardia. * Active liver disease or hepatic dysfunction, defined as AST or ALT \> 3 times the ULN. * Comorbidity with life expectancy \<= 2 years. * Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2. * Subject is currently participating in another investigational drug or device clinical study. * Presence of other anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Primary outcome measure(s)

  • The rate of MACCE between patients with and without CMD based on MRR at 1-year follow-up. — 12 months follow-up
    Rate of Major Adverse Cardiac and Cerebrovascular Events at one year (MACCE defined as cardiovascular death, angina and heart failure related hospitalisations and stroke) between patients with and without Coronary Microvascular Disease (CMD) defined according to thermodilution derived metrics (Microvascular Resistance Reserve, MRR).

Trial sites (19)

FacilityCityRegionStatus
OLV Ziekenhuis Aalst Aalst Belgium
Righospitalet Copenhagen Denmark
University of Mainz Mainz Germany
Catharina Hospital Eindhoven Netherlands
Radboud Hospital Nijmegen Netherlands
Maasstad Ziekenhuis Rotterdam Netherlands
University Clinical Center of Serbia, University of Belgrade Belgrade Serbia
University Hospital Puerta del Mar Cadiz Spain
Clinica La Princesa Madrid Spain
San Carlos Hospital Madrid Spain
University Hospital Lausanne Lausanne Switzerland
Royal United Hospital Bath NHS Foundation Trust Bath United Kingdom
Bristol Heart Institute Bristol United Kingdom
Basildon Hospital Essex United Kingdom
Golden Jubilee National Hospital Glasgow United Kingdom
Imperial College London United Kingdom
Royal Brompton Hospital London United Kingdom
St. Thomas Hospital, King's College London United Kingdom
Oxford University Hospitals Oxford United Kingdom

More CoreAalst BV trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05805462 on ClinicalTrials.gov ↗ ← All trials in Spain