Renal Arteries Dysplastic Aneurysms: Anatomopathological and Genetic Study

NCT ID: NCT02528149

Last Updated: 2015-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromuscular Dysplasia Renal Artery Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

tissue of adjacent part and aneurysm of renal aneurysm

Intervention Type PROCEDURE

the samples are collected during surgery of renal artery aneurysms. Th tissue is cryopreserved in liquid nitrogen before analysis

blood sample

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

blood sample

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xavier Barral, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CH Henri Mondor

Aurillac, , France

Site Status

CH Louis Pasteur

Bagnols-sur-Cèze, , France

Site Status

CHU Saint-Jacques

Besançon, , France

Site Status

Groupe Hospitalier Pellegrin

Bordeaux, , France

Site Status

Clinique Saint-Germain

Brive-la-Gaillarde, , France

Site Status

Centre Hospitalier A. Gayraud

Carcassonne, , France

Site Status

CH W. Morey

Chalon-sur-Saône, , France

Site Status

Hôpital Gabriel Montpied

Clermont-Ferrand, , France

Site Status

CH Emile Roux

Le Puy-en-Velay, , France

Site Status

Hôpital Jeanne de Flandre

Lille, , France

Site Status

Hôpital de la mère et de l'enfant

Limoges, , France

Site Status

Hôpital Robert Schuman

Metz, , France

Site Status

Hôpital Lapeyronie

Montpellier, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

CH Niort

Niort, , France

Site Status

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

CHRU Tours

Tours, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1308016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.