Clinical trial NCT02528149: Renal Arteries Dysplastic Aneurysms: Anatomopathological and Genetic Study
Official title: Renal Arteries Dysplastic Aneurysms: Anatomopathological and Genetic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromuscular Dysplasia
Renal Artery Stenosis
Keywords: Fibromuscular Dysplasia
dysplastic renal artery aneurysm
renal artery aneurysms
non atheromatous
dysplastic
anatomopathologic
genetic
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 34
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion 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 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: anatomopathological characteristics of renal aneurysms
timeFrame: day 1
Secondary outcomes:
measure: genetic markers in blood samples
timeFrame: day 1
measure: genetic markers in aneurysm tissue
timeFrame: day 1
Other outcomes:
Locations:
city: Aurillac
country: France
facility: CH Henri Mondor
city: Bagnols sur Cèze
country: France
facility: CH Louis Pasteur
city: Besançon
country: France
facility: CHU Saint-Jacques
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Brive-La-Gaillarde
country: France
facility: Clinique Saint-Germain
city: Carcassonne
country: France
facility: Centre Hospitalier A. Gayraud
city: Chalon sur Saone
country: France
facility: CH W. Morey
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Le Puy en Velay
country: France
facility: CH Emile Roux
city: Lille
country: France
facility: Hôpital Jeanne de Flandre
city: Limoges
country: France
facility: Hôpital de la mère et de l'enfant
city: Metz
country: France
facility: Hôpital Robert Schuman
city: Montpellier
country: France
facility: Hôpital Lapeyronie
city: Nantes
country: France
facility: CHU Nantes
city: Niort
country: France
facility: CH Niort
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Tours
country: France
facility: CHRU Tours
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Xavier Barral, PhD
role: PRINCIPAL_INVESTIGATOR
References: