Cross-sectional Study of Patients With Renal or Craniocervical Fibromuscular Dysplasia

NCT02884141 | Completed

• 2 other identifiers: P071241-Arcadia2009-A00288-49
• Study Type: observational
• Target: 499
• Locations: 2 countries
• Sites: 17

Brief Summary

ARCADIA is a national registry designed to document phenotypic and genetic traits in patients with renal and/or cervical artery fibromuscular dysplasia (FMD). FMD is a group of arterial diseases that most commonly involve renal and carotid arteries. Patients with FMD may present with renovascular hypertension and/or with cerebrovascular symptoms. Angiographic classification includes the multifocal type and the focal type. FMD may affect one or more vascular beds and progress to more severe stenosis and to renal or cerebrovascular complications. FMD may be familial (OMIM #135580). Our main objective is to create a FMD registry that will collect standardized information from all consenting patients diagnosed with the condition in 16 participating centers. This registry, along with a collection of leukocyte DNA, will constitute a resource for further clinical research on FMD. The first application will be the assessment of the frequency of multi-site FMD, i.e. the frequency of cervical artery FMD in patients presenting with renal artery FMD and vice-versa. The second application will be a case-control study to identify susceptibility genes for FMD. Patients are eligible in the registry if: (a) they have renal or cervical artery FMD with either multifocal or focal lesions at CT-angiography, MR-angiography, or intra-arterial angiography; (b) they give informed consent to leukocyte DNA analysis and to the collection of bioclinical and morphologic information. Phenotypic assessment will be performed in accordance with current recommendations and best clinical practice. Given the multicenter nature of the study and the recruitment capacity of each centre, enrollment of 500 FMD cases is expected over 5 years. This number will 1) allow an accurate estimation of the frequency of multi-site FMD: when the sample size is 500, a two-sided 95% confidence interval will extend 0.035 from the observed proportion for an expected proportion of 0.20 based on a previous report and from our unpublished data. 2) In addition to a collection of 400 renal FMD already collected at HEGP, give sufficient power for a genome-wide association study seeking for susceptibility genes

Conditions

Fibromuscular Dysplasia

Keywords

Renal Artery Obstruction; Carotid Artery Diseases; Genetic Association Studies

Outcome Measures

Primary Outcomes (1)

• Prevalence of multisite fibromuscular dysplasia confirmed by imaging

  FMD lesions discovered outside the symptomatic site

  Inclusion

Secondary Outcomes (2)

• Clinical characteristics associated with multisite fibromuscular dysplasia

  Inclusion

• Single nucleotide polymorphisms

  Inclusion

Study Arms (1)

Patients

Patients with documented fibromuscular dysplasia (see inclusion criteria). Non-usual care added acts: * blood sampling * urine sampling * renal echography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with renal or craniocervical fibromuscular dysplasia

You may qualify if:

• Who understood and signed inform consent form
• Affiliated to the French health insurance system
• The fibromuscular dysplasia is documented by imaging (angiography, CT-angiography, MR-angiography) of less than 4 years and validated by a radiologist investigator

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation de Recherche sur l'Hypertension Artérielle: collaborator

Study Sites (17)

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Location

CHU de Bordeaux hopital Saint-Andre

Bordeaux, Aquitaine-Limousin-Poitou-Charentes, 33000, France

Location

CHU de Clermont-Ferrand hopital Gabriel-Montpied

Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000, France

Location

CHU de Grenoble hopital Albert-Michallon

La Tronche, Auvergne-Rhône-Alpes, 38700, France

Location

CHU de Nancy institut Louis-Mathieu

Vandœuvre-lès-Nancy, Grand Est, 54500, France

Location

CHRU de Lille hopital cardiologique

Lille, Hauts-de-France, 59000, France

Location

CHRU de Lille hopital Roger-Salengro

Lille, Hauts-de-France, 59000, France

Location

CHU de Caen hopital Cote de Nacre

Caen, Normandy, 14000, France

Location

CHU de Toulouse hopital Rangueil

Toulouse, Occitanie, 31000, France

Location

AP-HM hopital de la Timone

Marseille, Provence-Alpes-Côte d'Azur Region, 13385, France

Location

Centre Hospitalier de Versailles hopital Andre Mignot

Le Chesnay, Île-de-France Region, 78157, France

Location

AP-HP hopital Lariboisiere

Paris, Île-de-France Region, 75010, France

Location

AP-HP hopital Pitie-Salpetriere

Paris, Île-de-France Region, 75013, France

Location

Centre hospitalier Sainte-Anne

Paris, Île-de-France Region, 75014, France

Location

AP-HP hopital Bichat-Claude-Bernard

Paris, Île-de-France Region, 75018, France

Location

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, 75018, France

Location

AP-HP hopital Tenon

Paris, Île-de-France Region, 75020, France

Location

Related Publications (2)

• Arnaud C, Boulanger M, Lorthioir A, Amar L, Azarine A, Boyer L, Chatellier G, Di Monaco S, Jeunemaitre X, Kastler A, Mousseaux E, Oppenheim C, Thony F, Persu A, Olin JW, Azizi M, Touze E; ARCADIA Co-investigators dagger. Male Sex Is Associated With Cervical Artery Dissection in Patients With Fibromuscular Dysplasia. J Am Heart Assoc. 2021 Jun;10(11):e018311. doi: 10.1161/JAHA.120.018311. Epub 2021 May 17.

  PMID: 33998257 DERIVED

• Plouin PF, Baguet JP, Thony F, Ormezzano O, Azarine A, Silhol F, Oppenheim C, Bouhanick B, Boyer L, Persu A, Hammer F, Gosse P, Mounier-Vehier C, Le Hello C, Jeunemaitre X, Azizi M, Amar L, Chatellier G, Mousseaux E, Touze E; ARCADIA Investigators. High Prevalence of Multiple Arterial Bed Lesions in Patients With Fibromuscular Dysplasia: The ARCADIA Registry (Assessment of Renal and Cervical Artery Dysplasia). Hypertension. 2017 Sep;70(3):652-658. doi: 10.1161/HYPERTENSIONAHA.117.09539. Epub 2017 Jul 17.

  PMID: 28716989 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Fibromuscular Dysplasia; Renal Artery Obstruction; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Pierre-Francois Plouin, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: November 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 2, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

FR (16); BE (1)