Fibromuscular DysplasiaNCT02528149
Renal Arteries Dysplastic Aneurysms: Anatomopathological and Genetic Study
An observational study of Fibromuscular Dysplasia and Renal Artery Stenosis, run by Centre Hospitalier Universitaire de Saint Etienne at 17 sites in France.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Fibromuscular Dysplasia, Renal Artery Stenosis
- What is being tested?
- tissue of adjacent part and aneurysm of renal aneurysm and blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 17 sitesFrance
- Study dates
- Sep 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
CH Henri Mondor
Aurillac
CH Louis Pasteur
Bagnols-sur-Cèze
CHU Saint-Jacques
Besançon
Groupe Hospitalier Pellegrin
Bordeaux
Clinique Saint-Germain
Brive-la-Gaillarde
Centre Hospitalier A. Gayraud
Carcassonne
CH W. Morey
Chalon-sur-Saône
Hôpital Gabriel Montpied
Clermont-Ferrand
CH Emile Roux
Le Puy-en-Velay
Hôpital Jeanne de Flandre
Lille
Hôpital de la mère et de l'enfant
Limoges
Hôpital Robert Schuman
Metz
Hôpital Lapeyronie
Montpellier
CHU Nantes
Nantes
CH Niort
Niort
Hôpital Européen Georges Pompidou
Paris
CHRU Tours
Tours
About this study
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.
- Conditions
- Fibromuscular Dysplasia, Renal Artery Stenosis
- Being tested
- tissue of adjacent part and aneurysm of renal aneurysm, blood sample
- Keywords
- Fibromuscular Dysplasia, dysplastic renal artery aneurysm, renal artery aneurysms, non atheromatous, dysplastic, anatomopathologic, genetic
- Medical subject headings
- Fibromuscular Dysplasia, Renal Artery Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue of adjacent part and aneurysm of renal aneurysmProcedure or surgery
the samples are collected during surgery of renal artery aneurysms. Th tissue is cryopreserved in liquid nitrogen before analysis
blood sampleOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: tissue of adjacent part and aneurysm of renal aneurysm; Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1
Secondary outcomes (2)
genetic markers in blood samples
identify specific genetic markers (mutation, variant) to characterize genes involved in fibromuscular dysplasia
Measured: day 1
genetic markers in aneurysm tissue
identify specific genetic markers (mutation, variant) to characterize genes involved in fibromuscular dysplasia
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromuscular DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Barral, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528149
- Sponsor's protocol ID
- 1308016
- Status last verified
- Aug 2015
- First submitted
- 18 Aug 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Arteries Dysplastic Aneurysms: Anatomopathological and Genetic Study
- ClinicalTrials.gov ID
- NCT02528149
- Acronym / sponsor ID
- 1308016
- Conditions
- Fibromuscular Dysplasia, Renal Artery Stenosis
- Keywords
- Fibromuscular Dysplasia, dysplastic renal artery aneurysm, renal artery aneurysms, non atheromatous, dysplastic, anatomopathologic, genetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with renal aneurysm | – | Procedure: tissue of adjacent part and aneurysm of renal aneurysm, Other: blood samplePatient with one or more renal artery aneurysm (RAA) operated and with tissue; adjacent part and aneurysm; cryopreserved. Blood sample performed at day 1. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tissue of adjacent part and aneurysm of renal aneurysmthe samples are collected during surgery of renal artery aneurysms. Th tissue is cryopreserved in liquid nitrogen before analysis | Procedure or surgery | patients with renal aneurysm |
| blood sample | Other | patients with renal aneurysm |
Primary outcome
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.
2 secondary outcomes
genetic markers in blood samples
Time frame: day 1
genetic markers in aneurysm tissue
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Barral, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromuscular Dysplasia and Renal Artery Stenosis, run by Centre Hospitalier Universitaire de Saint Etienne at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anatomopathological characteristics of renal aneurysms (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.