Cohort Follow-up of Patients With Renal or Craniocervical Fibromuscular Dysplasia
PROFILE
PROgression of FIbromuscular LEsions
3 other identifiers
interventional
340
2 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2009
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 7, 2016
CompletedFirst Posted
Study publicly available on registry
November 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedSeptember 23, 2019
September 1, 2019
8.2 years
November 7, 2016
September 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression of fibromuscular dysplasia lesions confirmed by imaging
3 years
Secondary Outcomes (11)
Glomerular filtration rate (GFR)
Inclusion, 3 years
Kidney height
Inclusion, 3 years
Clinical event: revascularization procedure in a lesion site
Through study completion
Clinical event: renal infarction
Through study completion
Clinical event: ischemic stroke
Through study completion
- +6 more secondary outcomes
Study Arms (1)
Prospective cohort
EXPERIMENTAL3 years follow-up
Interventions
Abdominal and supra-aortic trunks vascular imaging (angiography, CT-angiography or MR-angiography) will be performed 3 years after inclusion. This imaging will be compare to initial imaging (which is a part of usual care, not an intervention added by the study) in order to assess FMD progression.
A sample of blood will be taken to meet the objective of estimating the rate of genetic polymorphism that may influence disease progression or be associated with complications.
A sample of blood will be taken to biomarkers analysis to meet the primary objective of assessing the risk factors for progression of FMD lesions.
A sample of urine will be taken to biomarkers analysis to meet the primary objective of assessing the risk factors for progression of FMD lesions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, 1200, Belgium
CHU de Bordeaux hopital Saint-Andre
Bordeaux, Aquitaine-Limousin-Poitou-Charentes, 33000, France
CHU de Clermont-Ferrand hopital Gabriel-Montpied
Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000, France
CHU de Grenoble hopital Albert-Michallon
La Tronche, Auvergne-Rhône-Alpes, 38700, France
CHU de Nancy institut Louis-Mathieu
Vandeuvre-les-Nancy, Grand Est, 54500, France
CHRU de Lille hopital cardiologique
Lille, Hauts-de-France, 59000, France
CHRU de Lille hopital Roger-Salengro
Lille, Hauts-de-France, 59000, France
CHU de Caen hopital Cote de Nacre
Caen, Normandy, 14000, France
CHU de Toulouse hopital Rangueil
Toulouse, Occitanie, 31000, France
AP-HM hopital de la Timone
Marseille, Provence-Alpes-Côte d'Azur Region, 13385, France
Centre Hospitalier de Versailles hopital Andre Mignot
Le Chesnay, Île-de-France Region, 78157, France
AP-HP hopital Lariboisiere
Paris, Île-de-France Region, 75010, France
AP-HP hopital Pitie-Salpetriere
Paris, Île-de-France Region, 75013, France
Centre hospitalier Sainte-Anne
Paris, Île-de-France Region, 75014, France
Groupe Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region, 75015, France
AP-HP hopital Bichat-Claude-Bernard
Paris, Île-de-France Region, 75018, France
AP-HP hopital Tenon
Paris, Île-de-France Region, 75020, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre-François Plouin, MD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2016
First Posted
November 11, 2016
Study Start
November 1, 2009
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
September 23, 2019
Record last verified: 2019-09