Actively Recruiting

Phase Not Applicable
All Genders
NCT04804683

European/International FMD Registry and Initiative

Led by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Updated on 2022-05-05

5000

Participants Needed

1

Research Sites

521 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

European/International FMD Registry and Initiative

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with established Fibromuscular Dysplasia showing at least one string-of-beads or focal artery narrowing
  • Patients with Spontaneous Coronary Artery Dissection and at least one multifocal FMD lesion in arteries outside the heart
  • Patients under 60 years old with at least one artery dissection or two aneurysms without typical FMD signs or inherited artery disease
Not Eligible

You will not qualify if you...

  • Diagnosis based only on ultrasound without confirmation by CT angiography, MR angiography, or catheter-based angiography

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cliniques Universitaires Saint-Luc

Brussels, Belgium, 1200

Actively Recruiting

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Research Team

A

Alexandre Persu, MD-PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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