European/International FMD Registry and Initiative

NCT04804683 | Recruiting

• 1 other identifier: 2015/28AOU/464
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromuscular Dysplasia

Outcome Measures

Primary Outcomes (1)

• Wide-scale analysis of characteristics and progression of Fibromuscular Dysplasia

  Wide-scale analysis of baseline clinical characteristics and predictors of evolution/complications of Fibromuscular Dysplasia

  10 years

Study Arms (1)

Cohort of patients with Fibromuscular Dysplasia

OTHER

Intervention consists in blood/urine sampling

Genetic: Genetic dissection of Fibromuscular Dysplasia; Other: Search for diagnostic and prognostic biomarkers of Fibromuscular Dysplasia

Interventions

Genetic dissection of Fibromuscular Dysplasia GENETIC

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

Cohort of patients with Fibromuscular Dysplasia

Search for diagnostic and prognostic biomarkers of Fibromuscular Dysplasia OTHER

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

Cohort of patients with Fibromuscular Dysplasia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Fibromuscular Dysplasia

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alexandre Persu, MD-PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Persu, MD-PhD

CONTACT

0032 2 764 63 06; alexandre.persu@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study is interventional because it requires blood/urine sampling.

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 18, 2021
• Study Start: March 11, 2021
• Primary Completion: December 31, 2022
• Study Completion (Estimated): March 10, 2031
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)