The European/International FMD Registry and Initiative (FEIRI), a Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Genetic, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• (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.

Locations
Other Locations
Belgium
Cliniques Universitaires Saint-Luc
RECRUITING
Brussels
Contact Information
Primary
Alexandre Persu, MD-PhD
alexandre.persu@uclouvain.be
0032 2 764 63 06
Time Frame
Start Date: 2021-03-11
Estimated Completion Date: 2031-03-10
Participants
Target number of participants: 5000
Treatments
Other: Cohort of patients with Fibromuscular Dysplasia
Intervention consists in blood/urine sampling
Related Therapeutic Areas
Sponsors
Leads: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

This content was sourced from clinicaltrials.gov