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)
Facility
City
Region
Status
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
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.
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