RecruitingNot ApplicableNCT04804683

European/International FMD Registry and Initiative

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


Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Enrollment

5,000 participants

Start Date

Mar 11, 2021

Study Type

INTERVENTIONAL

Conditions

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

Inclusion Criteria3

  • (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 Criteria1

  • Diagnosis based only on ultrasound (need for computed tomographic angiography , magnetic resonance angiography or catheter-based angiography to confirm the diagnosis)

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Interventions

GENETICGenetic dissection of Fibromuscular Dysplasia

Blood sampling for genetic analysis aiming at unraveling the genetic basis of Fibromuscular Dysplasia

OTHERSearch for diagnostic and prognostic biomarkers of Fibromuscular Dysplasia

Blood/urine and in rare cases tissue sampling aiming at identifying biomarkers of Fibromuscular Dysplasia


Locations(1)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

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NCT04804683


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