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Trial record 1 of 11 for:    Fibromuscular Dysplasia
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Pathophysiological Mechanisms of Fibromuscular Dysplasia (MeDyA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01935752
First Posted: September 5, 2013
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fondation pour la Recherche Médicale
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention
Fibromuscular Dysplasia Other: blood samples Other: vascular echotracking

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pathophysiological Mechanisms of Fibromuscular Dysplasia

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 150
Study Start Date: November 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fibromuscular dysplasia
Fibromuscular dysplasia:blood samples & vascular echotracking
Other: blood samples
blood samples
Other: vascular echotracking
endothelial function study and virtual histology study
healthy volunteer
healthy volunteer:blood samples & vascular echotracking
Other: blood samples
blood samples
Other: vascular echotracking
endothelial function study and virtual histology study
hypertensive patients
hypertensive patients:blood samples & vascular echotracking
Other: blood samples
blood samples
Other: vascular echotracking
endothelial function study and virtual histology study

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935752


Locations
France
Cic9201, Hegp, Aphp,
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fondation pour la Recherche Médicale
Investigators
Principal Investigator: Michel Azizi, MD, PhD. HEGP, APHP, Paris, France
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01935752     History of Changes
Other Study ID Numbers: P110301
First Submitted: September 2, 2013
First Posted: September 5, 2013
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
fibromuscular
dysplasia
endothelium
microparticles
microRNA

Additional relevant MeSH terms:
Hyperplasia
Fibromuscular Dysplasia
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases


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