Trial record 1 of 4 for:    Fibromuscular Dysplasia
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Pathophysiological Mechanisms of Fibromuscular Dysplasia (MeDyA)

This study is currently recruiting participants.
Verified July 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Fondation pour la Recherche Médicale
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01935752
First received: September 2, 2013
Last updated: NA
Last verified: July 2012
History: No changes posted
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of circulating micro RNAs (miR-143 ; miR-145) between the 3 arms [ Time Frame: Once within 15 days ] [ Designated as safety issue: No ]
  • Comparison of matrixmetalloproteases between the 3 arms [ Time Frame: Once within 15 days ] [ Designated as safety issue: No ]
  • Comparison of c-reactive protein between the 3 arms [ Time Frame: Once within 15 days ] [ Designated as safety issue: No ]
  • Comparison of PLA2 between the 3 arms [ Time Frame: Once within 15 days ] [ Designated as safety issue: No ]
  • Comparison of endothelium dependant vasodilation between the 3 arms [ Time Frame: Once within 15 days ] [ Designated as safety issue: No ]
  • Comparison of endothelium independent vasodilation between the 3 arms [ Time Frame: Once within 15 days ] [ Designated as safety issue: No ]
  • Comparison of pulse wave velocity between the 3 arms [ Time Frame: Once within 15 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2011
Estimated Study Completion Date: October 2014
Estimated 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01935752

Contacts
Contact: Michael Frank, MD, Msc. 0156093066 ext 01133 michael.frank@egp.aphp.fr
Contact: Michel Azizi, MD, PhD. 0156092945 ext 01133 michel.azizi@egp.aphp.fr

Locations
France
Cic9201, Hegp, Aphp, Recruiting
Paris, France, 75015
Contact: Michael Frank, MD, Msc    0156093066 ext 01133    michael.frank@egp.aphp.fr   
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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01935752     History of Changes
Other Study ID Numbers: P110301
Study First Received: September 2, 2013
Last Updated: September 2, 2013
Health Authority: France: Committee for the Protection of Personnes

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

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

ClinicalTrials.gov processed this record on April 17, 2014