Renal Arteries Dysplastic Aneurysms: Anatomopathological and Genetic Study

August 18, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aurillac, France
        • CH Henri Mondor
      • Bagnols sur Cèze, France
        • CH Louis Pasteur
      • Besançon, France
        • CHU Saint-Jacques
      • Bordeaux, France
        • Groupe Hospitalier Pellegrin
      • Brive-La-Gaillarde, France
        • Clinique Saint-Germain
      • Carcassonne, France
        • Centre Hospitalier A. Gayraud
      • Chalon sur Saone, France
        • Ch W. Morey
      • Clermont-Ferrand, France
        • Hôpital Gabriel Montpied
      • Le Puy en Velay, France
        • CH Emile Roux
      • Lille, France
        • Hopital Jeanne de Flandre
      • Limoges, France
        • Hôpital de la mère et de l'enfant
      • Metz, France
        • Hôpital Robert Schuman
      • Montpellier, France
        • Hôpital Lapeyronie
      • Nantes, France
        • CHU Nantes
      • Niort, France
        • CH Niort
      • Paris, France
        • Hôpital Européen Georges Pompidou
      • Tours, France
        • CHRU Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: blood sample
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anatomopathological characteristics of renal aneurysms
Time Frame: day 1
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
genetic markers in blood samples
Time Frame: day 1
identify specific genetic markers (mutation, variant) to characterize genes involved in fibromuscular dysplasia
day 1
genetic markers in aneurysm tissue
Time Frame: day 1
identify specific genetic markers (mutation, variant) to characterize genes involved in fibromuscular dysplasia
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Xavier Barral, PhD, Chu Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 18, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1308016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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