Registry for patients with coronary microvascular disease
European microCirculatory Resistance and Absolute Flow Team: The Euro-CRAFT Registry
This study is trying to gather information about how well the tiny blood vessels in the heart are working in people who have chest pain but no major blockages in their arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 671 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CoreAalst BV Industry-sponsored |
| Locations | 19 sites (Aalst and 18 other locations) |
| Trial ID | NCT05805462 on ClinicalTrials.gov |
What this trial studies
The Euro-CRAFT Registry is an international, multicentric observational registry that focuses on patients undergoing functional assessment of the coronary microcirculation using the continuous thermodilution technique. Participants will complete angina and quality of life questionnaires at baseline, 6 months, and 1-year follow-up, with clinical follow-up extending optionally to 5 years. The study aims to gather comprehensive data on the functional status of the coronary microvasculature in patients with suspected angina and non-obstructive coronary arteries.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with stable chest pain suspected of angina and non-obstructive coronary arteries.
Not a fit: Patients with unstable hemodynamics, ongoing chest pain, or significant comorbidities may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of coronary microvascular disease and improve management strategies for patients experiencing angina.
How similar studies have performed: While this registry approach is not novel, it builds on previous observational studies that have successfully assessed coronary microvascular function.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aalst and 18 other locations
- OLV Ziekenhuis Aalst — Aalst, Belgium (Recruiting)
- Righospitalet — Copenhagen, Denmark (Recruiting)
- University of Mainz — Mainz, Germany (Recruiting)
- Catharina Hospital — Eindhoven, Netherlands (Recruiting)
- Radboud Hospital — Nijmegen, Netherlands (Recruiting)
- Maasstad Ziekenhuis — Rotterdam, Netherlands (Recruiting)
- University Clinical Center of Serbia, University of Belgrade — Belgrade, Serbia (Recruiting)
- University Hospital Puerta del Mar — Cadiz, Spain (Recruiting)
- Clinica La Princesa — Madrid, Spain (Recruiting)
- San Carlos Hospital — Madrid, Spain (Recruiting)
- University Hospital Lausanne — Lausanne, Switzerland (Recruiting)
- Royal United Hospital Bath NHS Foundation Trust — Bath, United Kingdom (Recruiting)
- Bristol Heart Institute — Bristol, United Kingdom (Recruiting)
- Basildon Hospital — Essex, United Kingdom (Recruiting)
- Golden Jubilee National Hospital — Glasgow, United Kingdom (Recruiting)
- Imperial College — London, United Kingdom (Recruiting)
- Royal Brompton Hospital — London, United Kingdom (Recruiting)
- St. Thomas Hospital, King's College — London, United Kingdom (Recruiting)
- Oxford University Hospitals — Oxford, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Sofie Pardaens, PhD
- Email: sofiepardaens@coreaalst.com
- Phone: 0032 53 72 42 30
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.