Pathophysiological Mechanisms of Fibromuscular Dysplasia (MeDyA)

October 17, 2016 updated by: Assistance Publique - Hôpitaux de Paris
Fibromuscular dysplasia is an non inflammatory non atherosclerotic obstructive arterial disease affecting mid-size arteries. It is considered as a rare vascular disease of unknown origin. Fibromuscular dysplasia may become symptomatic depending on location and severity of narrowing of the arterial lumen. for example,when a stenosis develops within a renal artery, arterial hypertension may develop. The cause of fibromuscular dysplasia is unknown. Several factors have been suggested to be associated with it: tobacco abuse or oestrogens. In order to progress into identifying possible causative mechanisms of the disease, we design a pathophysiology study destined to assess endothelial function in patients with fibromuscular dysplasia and to identify possible plasmatic biomarkers of the disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

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
      • Paris, France, 75015
        • Cic9201, Hegp, Aphp,

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria for patients with multifocal fibromuscular dysplasia:

  • confirmed multifocal fibromuscular dysplasia
  • diagnosed for less than 10 years
  • without significant atherosclerotic disease or recent cardiovascular event
  • Statins and antiplatelet drugs are forbidden
  • hypertensive patients

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

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fibromuscular dysplasia
Fibromuscular dysplasia:blood samples & vascular echotracking
Other: blood samples
blood samples
Other: vascular echotracking
endothelial function study and virtual histology study
Other: healthy volunteer
healthy volunteer:blood samples & vascular echotracking
Other: blood samples
blood samples
Other: vascular echotracking
endothelial function study and virtual histology study
Other: hypertensive patients
hypertensive patients:blood samples & vascular echotracking
Other: blood samples
blood samples
Other: vascular echotracking
endothelial function study and virtual histology study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of circulating microparticles of patients vs. fibromuscular dysplasia with age and sex matched healthy volunteers and hypertensive patients
Time Frame: Once within 15 days
Once within 15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of circulating micro RNAs (miR-143 ; miR-145) between the 3 arms
Time Frame: Once within 15 days
Once within 15 days
Comparison of matrixmetalloproteases between the 3 arms
Time Frame: Once within 15 days
Once within 15 days
Comparison of c-reactive protein between the 3 arms
Time Frame: Once within 15 days
Once within 15 days
Comparison of PLA2 between the 3 arms
Time Frame: Once within 15 days
Once within 15 days
Comparison of endothelium dependant vasodilation between the 3 arms
Time Frame: Once within 15 days
Once within 15 days
Comparison of endothelium independent vasodilation between the 3 arms
Time Frame: Once within 15 days
Once within 15 days
Comparison of pulse wave velocity between the 3 arms
Time Frame: Once within 15 days
Once within 15 days

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Fondation pour la Recherche Médicale

Investigators

  • Principal Investigator: Michel Azizi, MD, PhD., HEGP, APHP, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 2, 2013

First Submitted That Met QC Criteria

September 2, 2013

First Posted (Estimate)

September 5, 2013

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P110301

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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