Renal Arteries Dysplastic Aneurysms: Anatomopathological and Genetic Study
1 other identifier
observational
34
1 country
17
Brief Summary
Fibromuscular dysplasia (FMD) is localized structural defects in the arterial wall, whose innate or acquired character is still unknown. This segmental non atheromatous injury, leads to stenosis of the arteries of small and medium caliber. Renal arteries are the most commonly affected with 60-75% of total fibrodysplasia. Three histological subtypes have been described: intimal, medial and peri-medial. They are not mutually exclusive and can be observed in the same patient. This is a rare blood disease, occurring in children and young adults. In this young population with long life expectancy, these aneurysmal lesion are associated with 10% risk of rupture. To date, no data have shown in the literature that FMD is link to genetic causes, or if there is specific histopathologic lesions for non-atherosclerotic renal artery aneurysms. To answer these questions, Cardiovascular Surgery Unit of the University Hospital of Saint-Etienne, French national reference center for renal artery surgery, in association with the Reference Center for Rare Vascular Disease in Paris, designed the first study for pathological and genetic characteristics of dysplastic renal artery aneurysms in young patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2013
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 18, 2015
CompletedFirst Posted
Study publicly available on registry
August 19, 2015
CompletedAugust 19, 2015
August 1, 2015
1.2 years
August 18, 2015
August 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
anatomopathological characteristics of renal aneurysms
Anatomopathological criteria is a composite outcome : Presence of a media thickness, the media disappearance zones, loss of smooth muscle cells (SMC) in the media with replacement by fibrosis, disorganization of SMC, aneurysms, dissections, discontinuity of the internal elastic lamina, and intimal thickening due to myointimal hyperplasia, abnormalities of proteins of the extracellular matrix.
day 1
Secondary Outcomes (2)
genetic markers in blood samples
day 1
genetic markers in aneurysm tissue
day 1
Study Arms (1)
patients with renal aneurysm
Patient with one or more renal artery aneurysm (RAA) operated and with tissue; adjacent part and aneurysm; cryopreserved. Blood sample performed at day 1.
Interventions
the samples are collected during surgery of renal artery aneurysms. Th tissue is cryopreserved in liquid nitrogen before analysis
Eligibility Criteria
Patients with one or more Renal artery aneurysm (RAA), not eligible for endovascular treatment, have been operated at the Hospital of Saint-Etienne, with tissue (adjacent part and aneurysm) cryopreserved in liquid nitrogen in renal lab and then sent in genetic lab in EHGP.
You may qualify if:
- Patients with one or more Renal artery aneurysm (RAA), not eligible for endovascular treatment, have been operated at the Hospital of Saint-Etienne, with tissue (adjacent part and aneurysm) cryopreserved in liquid nitrogen in renal lab and then sent in genetic lab in Georges Pompidou European Hospital (EHGP ).
- Patient (or parent/person having parental authority) Affiliate or entitled to a social security scheme.
- Signature of patient consent (or parents or holder of parental authority)
You may not qualify if:
- Patient not included in the tissue collection in Georges Pompidou European Hospital (EHGP ).
- Patient refusing to participate in the study and / or genetic analysis or, for juvenile patients, parents or holder of parental authority refusing the minor patient to be involved in the study and / or genetic analysis.
- Patient with FMD whose samples in the tissue collection did not concern aneurysm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
CH Henri Mondor
Aurillac, France
CH Louis Pasteur
Bagnols-sur-Cèze, France
CHU Saint-Jacques
Besançon, France
Groupe Hospitalier Pellegrin
Bordeaux, France
Clinique Saint-Germain
Brive-la-Gaillarde, France
Centre Hospitalier A. Gayraud
Carcassonne, France
CH W. Morey
Chalon-sur-Saône, France
Hôpital Gabriel Montpied
Clermont-Ferrand, France
CH Emile Roux
Le Puy-en-Velay, France
Hôpital Jeanne de Flandre
Lille, France
Hôpital de la mère et de l'enfant
Limoges, France
Hôpital Robert Schuman
Metz, France
Hôpital Lapeyronie
Montpellier, France
CHU Nantes
Nantes, France
CH Niort
Niort, France
Hôpital Européen Georges Pompidou
Paris, France
CHRU Tours
Tours, France
Biospecimen
blood samples and adjacent part and aneurysm of renal aneurysms
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xavier Barral, PhD
CHU SAINT-ETIENNE
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2015
First Posted
August 19, 2015
Study Start
September 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 19, 2015
Record last verified: 2015-08