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OpenTrials
Completed

NCT Number: NCT01935752

Pathophysiological Mechanisms of Fibromuscular Dysplasia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cic9201, Hegp, Aphp,

Paris, 75015, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Samples

Other

blood samples

vascular echotracking

Other

endothelial function study and virtual histology study

Primary outcomes

  1. 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 outcomes

  1. Comparison of circulating micro RNAs (miR-143 ; miR-145) between the 3 arms

    Time frame: Once within 15 days

  2. Comparison of matrixmetalloproteases between the 3 arms

    Time frame: Once within 15 days

  3. Comparison of c-reactive protein between the 3 arms

    Time frame: Once within 15 days

  4. Comparison of PLA2 between the 3 arms

    Time frame: Once within 15 days

  5. Comparison of endothelium dependant vasodilation between the 3 arms

    Time frame: Once within 15 days

  6. Comparison of endothelium independent vasodilation between the 3 arms

    Time frame: Once within 15 days

  7. Comparison of pulse wave velocity between the 3 arms

    Time frame: Once within 15 days

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Fondation pour la Recherche Médicale

Registry information

Acronym: MeDyA

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 5, 2013
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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