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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014