PROgression of FIbromuscular LEsions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 340
- Locations
- 17
- Primary Endpoint
- Progression of fibromuscular dysplasia lesions confirmed by imaging
Study Overview
Brief Summary
PROFILE is a cohort study evaluating the progression of fibromuscular dysplasia lesions. This study is the prospective dimension of ARCADIA registry (ClinicalTrials.gov Identifier: NCT02884141), which aims to document phenotypic and genetic traits in patients with renal and/or cervical artery fibromuscular dysplasia.
Detailed Description
Background
Fibromuscular dysplasia (FMD) is a group of nonatherosclerotic, noninflammatory arterial diseases that usually involve renal and carotid arteries. Patients with FMD may present with renovascular hypertension and/or with cerebrovascular symptoms. The prevalence of FMD in hypertensive patients is estimated at 4/1000. Angiographic classification includes the multifocal type, with multiple stenoses and the 'string-of-beads' appearance that is related to medial FMD, and tubular and focal types which are not clearly related to specific histological lesions. FMD may affect one or more vascular beds and progress to more severe stenosis and to renal or cerebrovascular complications. FMD appears to be familial in 10% of cases (OMIM #135580).
Renal artery FMD may progress to more severe stenosis and to renal atrophy, and/or to stenoses affecting more arteries within or outside the renal vasculature. The risk of progression as assessed from available studies was probably overestimated because documentation of progression was obtained from angiography, a procedure which is not routinely undertaken in patients with favourable clinical and biological outcomes. The disease is progressive, however, and literature stated that patients with FMD should undergo yearly duplex ultrasonography to detect progression of disease, restenosis, or loss of kidney volume.
There are very few data on prognosis of patients with symptomatic carotid or vertebral artery FMD. The risk of arterial disease progression over time is unknown. The risk of ischemic stroke ranged from 0 to about 3% per year in the few studies which assessed that issue.
Objectives
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with renal or craniocervical fibromuscular dysplasia diagnosed during the 2 years before inclusion
- •The fibromuscular dysplasia is documented by imaging (angiography, CT-angiography, MR-angiography) of less than 2 years and validated by a radiologist investigator
- •Patient who understood and signed inform consent form
- •Affiliated to the French health insurance system
- •Available for a 3 years follow-up
Exclusion Criteria
- •Patient with renal or craniocervical atherosclerosis, or inflammatory vascular disease as dominant pathological features
- •Patient with renal or craniocervical arteries dissection or aneurysm without any other evidence of fibromuscular dysplasia
- •Patient under 18 or under tutorship
- •Known pregnancy
Arms & Interventions
Prospective cohort
3 years follow-up
Intervention: Blood sampling (genetic) (Genetic)
Prospective cohort
3 years follow-up
Intervention: Abdominal and supra-aortic trunks vascular imaging (Other)
Prospective cohort
3 years follow-up
Intervention: Blood sampling (biomarkers) (Other)
Prospective cohort
3 years follow-up
Intervention: Urine sampling (Other)
Outcomes
Primary Outcomes
Progression of fibromuscular dysplasia lesions confirmed by imaging
Time Frame: 3 years
Secondary Outcomes
- Matrix metalloproteinases level(Inclusion)
- Prevalence of multisite fibromuscular dysplasia confirmed by imaging(Inclusion, 3 years)
- Clinical event: renal infarction(Through study completion)
- Clinical event: revascularization procedure in a lesion site(Through study completion)
- Clinical event: arterial dissection in a lesion site or downstream from a lesion site(Through study completion)
- Glomerular filtration rate (GFR)(Inclusion, 3 years)
- Clinical event: ischemic stroke(Through study completion)
- Single nucleotide polymorphisms(Inclusion)
- Plasminogen/plasmin level(Inclusion)
- Clinical event: aneurysm rupture in a lesion site or downstream from a lesion site(Through study completion)
- Kidney height(Inclusion, 3 years)