Registry and initiative for Fibromuscular Dysplasia
The European/International FMD Registry and Initiative (FEIRI), a Prospective Study
This study is gathering information about Fibromuscular Dysplasia to better understand the condition and improve care for those affected.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5000 (estimated) |
| Sex | All |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT04804683 on ClinicalTrials.gov |
What this trial studies
This initiative aims to gather and analyze data on Fibromuscular Dysplasia (FMD) and related conditions globally. It will document demographic and arterial characteristics, evaluate the incidence of new FMD lesions, and investigate genetic and molecular mechanisms associated with the disease. Participants will provide clinical data retrospectively and prospectively, with an option to contribute to a biobank for further research. The study seeks to enhance understanding of FMD and its implications for patient care.
Who should consider this trial
Good fit: Ideal candidates include patients with established FMD, those with Spontaneous Coronary Artery Dissection (SCAD) showing FMD lesions, and individuals with atypical FMD presentations.
Not a fit: Patients whose diagnosis is based solely on ultrasound without confirmation from advanced imaging techniques will not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could lead to improved diagnosis, treatment, and management of Fibromuscular Dysplasia.
How similar studies have performed: Other studies have shown promise in understanding FMD through genetic and clinical data collection, making this initiative a continuation of established research efforts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
(i) Patients with established FMD, i.e at least one string-of-beads (multifocal FMD) or focal stenosis (focal FMD).
(ii) Patients with Spontaneous Coronary Artery Dissection (SCAD) in whom at least one lesion of multifocal FMD (string-of beads) in extra-coronary arteries has been identified ("SCAD-FMD").
(iii) Patients with so-called "atypical FMD" or "FMD-like presentation", i.e. patients presenting with at least one dissection or 2 aneurysms \< 60-year-old, in the absence string-of-beads, focal stenosis or evidence of inherited arteriopathy.
Exclusion Criteria:
Diagnosis based only on ultrasound (need for computed tomographic angiography , magnetic resonance angiography or catheter-based angiography to confirm the diagnosis)
Where this trial is running
Brussels
- Cliniques Universitaires Saint-Luc — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Alexandre Persu, MD-PhD — Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study coordinator: Alexandre Persu, MD-PhD
- Email: alexandre.persu@uclouvain.be
- Phone: 0032 2 764 63 06
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.