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

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ClinicalTrials.gov Identifier: NCT02884141
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : September 2, 2016
Sponsor:
Collaborator:
Fondation de Recherche sur l'Hypertension Artérielle
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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


Condition or disease
Fibromuscular Dysplasia

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Study Type : Observational
Actual Enrollment : 499 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Renal and Cervical Artery DysplasIA
Study Start Date : November 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Group/Cohort
Patients

Patients with documented fibromuscular dysplasia (see inclusion criteria).

Non-usual care added acts:

  • blood sampling
  • urine sampling
  • renal echography



Primary Outcome Measures :
  1. Prevalence of multisite fibromuscular dysplasia confirmed by imaging [ Time Frame: Inclusion ]
    FMD lesions discovered outside the symptomatic site


Secondary Outcome Measures :
  1. Clinical characteristics associated with multisite fibromuscular dysplasia [ Time Frame: Inclusion ]
  2. Single nucleotide polymorphisms [ Time Frame: Inclusion ]
    Assessed by genome-wide association


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with renal or craniocervical fibromuscular dysplasia
Criteria

Inclusion Criteria:

  • Patient with renal or craniocervical fibromuscular dysplasia diagnosed during the 4 years before inclusion
  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884141


Locations
Show Show 17 study locations
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fondation de Recherche sur l'Hypertension Artérielle
Investigators
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Principal Investigator: Pierre-Francois Plouin, MD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02884141    
Other Study ID Numbers: P071241-Arcadia
2009-A00288-49 ( Registry Identifier: ID-RCB (France: Agence Nationale de Securite du Medicament) )
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Controlled access
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Renal Artery Obstruction
Carotid Artery Diseases
Genetic Association Studies
Additional relevant MeSH terms:
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Fibromuscular Dysplasia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases