Actively Recruiting
The European/International Fibromuscular Dysplasia Registry and Initiative (FEIRI), a Prospective Study
Led by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Updated on 2022-05-05
5000
Participants Needed
1
Research Sites
427 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Fibromuscular dysplasia (FMD) is a condition affecting the muscles in arterial walls, causing narrowing in small and medium arteries. It includes multifocal FMD with alternating narrowings and dilations, and focal FMD with a single narrowing. This research aims to study FMD and related conditions like Spontaneous Coronary Artery Dissection (SCAD) and atypical FMD across many countries, focusing on patient demographics, disease characteristics, and underlying genetic and molecular factors. The study involves collecting standard clinical data from patients diagnosed with FMD, both retrospectively and during regular follow-up visits. Participants may also choose to provide blood, urine, and in some cases, tissue samples for genetic and proteomic analysis to identify biomarkers. Enrollment occurs at centers in over 20 countries, enabling a global perspective on the disease. During the study, researchers will analyze patient information and biological samples to understand FMD's progression and its genetic and molecular basis. The main outcome is a wide-scale analysis of disease features and progression over 10 years. Participants will undergo standard care visits, and data collection will continue throughout the study, with optional biobanking for additional research.
CONDITIONS
Brief Title
European/International FMD Registry and Initiative
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with established fibromuscular dysplasia, including multifocal (string-of-beads) or focal stenosis types
- Patients with Spontaneous Coronary Artery Dissection and at least one multifocal FMD lesion in extra-coronary arteries
- Patients with atypical FMD or FMD-like presentation with at least one dissection or two aneurysms under 60 years old without string-of-beads, focal stenosis, or inherited arteriopathy evidence
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants undergo blood, urine, and in rare cases tissue sampling to identify genetic and biomarker characteristics of Fibromuscular Dysplasia.
Visits occur during standard-of-care follow-up where samples are collected
Duration - Up to 10 years
Participants are observed for the progression and characteristics of Fibromuscular Dysplasia through ongoing data collection during routine clinical care.
Follow-up visits aligned with routine care over 10 years
Trial Site Locations
Total: 1 location
1
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
Research Team
A
Alexandre Persu, MD-PhD
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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