Pathophysiological Mechanisms of Fibromuscular Dysplasia

Study Overview
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Brief Summary
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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.

Official Title
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Pathophysiological Mechanisms of Fibromuscular Dysplasia

Conditions
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Fibromuscular Dysplasia

Intervention / Treatment
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* Other: blood samples
* Other: vascular echotracking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromuscular, dysplasia, endothelium, microparticles, microRNA