NCT04804683 European/International FMD Registry and Initiative
| NCT ID | NCT04804683 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
| Condition | Fibromuscular Dysplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2021-03-11 |
| Primary Completion | 2022-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5,000 participants in total. It began in 2021-03-11 with a primary completion date of 2022-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main objectives of FEIRI are: (i) To describe the demographic and arterial characteristics of FMD and related diseases at a global scale and according to countries and/or ethnic origin (ii) To evaluate the incidence and predictors of novel FMD lesions and complications (iii) To explore the commonalities and differences between FMD, SCAD and so-called atypical FMD (patients with multiple dissections and/or aneurysms without string-of-beads, focal stenosis or evidence of inherited arteriopathy) (iv) To contribute to the unravelling of genetic, proteomic and molecular mechanisms underlying FMD and related diseases Participation to the FEIRI study implies: (i) Collection of demographic and standard-of-care clinical data, both retrospectively (from the diagnosis of FMD to signature of the informed consent) and prospectively (on the occasion of standard-of-care follow-up). (ii) Optional participation to a biobank implying collection of blood, urine and, in rare cases of intervention, tissue samples for genomic and proteomic analysis and identification of diagnostic and prognostic biomarkers of FMD. Participants will be enrolled in centres from over 20 countries in Europe and beyond.
Eligibility 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)
Contact & Investigator
Alexandre Persu, MD-PhD
PRINCIPAL INVESTIGATOR
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Frequently Asked Questions
Who can join the NCT04804683 clinical trial?
This trial is open to participants of all sexes, studying Fibromuscular Dysplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04804683 currently recruiting?
Yes, NCT04804683 is actively recruiting participants. Contact the research team at alexandre.persu@uclouvain.be for enrollment information.
Where is the NCT04804683 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT04804683 clinical trial?
NCT04804683 is sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. The principal investigator is Alexandre Persu, MD-PhD at Cliniques universitaires Saint-Luc- Université Catholique de Louvain. The trial plans to enroll 5,000 participants.