MedTrace Logo

European/International FMD Registry and Initiative

NCT04804683 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2022-05-05

No results posted yet for this study

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

Interventions

GENETIC

Genetic dissection of Fibromuscular Dysplasia

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

OTHER

Search for diagnostic and prognostic biomarkers of Fibromuscular Dysplasia

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

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Alexandre Persu, MD-PhD · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-11
Primary Completion
2022-12-31
Completion
2031-03-10

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04804683 on ClinicalTrials.gov