Renal Arteries Dysplastic Aneurysms: Anatomopathological and Genetic Study

Renal Artery Stenosis Clinical Trial

Official title:

Renal Arteries Dysplastic Aneurysms: Anatomopathological and Genetic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528149
• Other study ID #: 1308016
• Status: Completed
• Phase: N/A
• First received: August 18, 2015
• Last updated: August 18, 2015
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Fibromuscular Dysplasia
• Renal Artery Obstruction
• Renal Artery Stenosis

Intervention

Procedure:
• tissue of adjacent part and aneurysm of renal aneurysm
the samples are collected during surgery of renal artery aneurysms. Th tissue is cryopreserved in liquid nitrogen before analysis

Other:
• blood sample

Locations

Country	Name	City	State
France	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 Saone
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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	genetic markers in blood samples	identify specific genetic markers (mutation, variant) to characterize genes involved in fibromuscular dysplasia	day 1	No
Secondary	genetic markers in aneurysm tissue	identify specific genetic markers (mutation, variant) to characterize genes involved in fibromuscular dysplasia	day 1	No