European/International FMD Registry and Initiative

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.

NCT Number	NCT04804683
Lead Sponsor	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions	Fibromuscular Dysplasia
Enrollment	5,000 participants
Start Date	2021-03-11
Primary Completion	2022-12-31 (estimated)
Study Completion	2031-03-10 (estimated)
Updated on ClinicalTrials.gov	2022-05-05