Defining the Basis of Fibromuscular Dysplasia (FMD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2030-12-31

Brief Summary

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The purpose of this study has evolved and expanded since its inception. Originally the intent was to establish the functional, molecular and genetic profile of fibroblasts from Fibromuscular Dysplasia (FMD) patients as compared to carefully matched control subjects. While this remains among the objectives, the study has been expanded to undertake a fully powered cross-tissue systems genetics analysis of FMD, and now also the related arteriopathies spontaneous coronary artery dissection (SCAD) and cervical artery dissection (CvAD). The overall objective is to disclose the core biologic mechanisms of these disorders.

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Detailed Description

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Specific aims

* Specific aim 1: To establish a library of fibroblasts, DNA, plasma and serum from patients with FMD, SCAD and CvAD and unaffected healthy control subjects.
* Specific aim 2: To perform a fully powered cross-tissue systems analysis of the key regulatory gene networks and disease drivers underlying FMD, SCAD and CvAD.
* Specific aim 3: To cross-compare the molecular and genomic profiles of FMD, SCAD and CvAD to establish the degree of biologic similarity among these disorders.

Conditions

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Fibromuscular Dysplasia Spontaneous Coronary Artery Dissection Cervical Artery Dissection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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FMD subjects

patients who fulfill standard diagnostic criteria for FMD

No interventions assigned to this group

SCAD subjects

patients who fulfill standard diagnostic criteria for SCAD

No interventions assigned to this group

CvAD subjects

patients who fulfill standard diagnostic criteria for CvAD

No interventions assigned to this group

Healthy control subjects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients of any age and freely willing to participate. For patients \< 18 years of age consent will be via parents.
* Fluency in either English or Spanish.
* Signed, informed consent
* For FMD, SCAD or CvAD subjects - a clinical diagnosis of FMD, SCAD or CvAD with fulfillment of standard diagnostic criteria.
* For healthy controls - no clinical features of FMD, SCAD or CvAD and absence of any major ongoing systemic disease including any condition requiring hospitalization, immune suppression, intravenous or injected medications or that result in functional impairment in the performance of activities of daily living. Healthy controls will be matched to enrolled FMD patients on the basis of gender and approximate age (within a 5 year window of another FMD subject).

Exclusion Criteria

* Patients who have co-morbidities which reduces life expectancy to one year.
* Patients with any solid organ or hematological transplantation, or those in whom transplantation is considered.
* Active autoimmune disease.
* Illicit drug use.
* HIV positive.
* Prior malignancy.
* Any other form of vascular disease, including other arteriopathy coronary artery disease or peripheral vascular disease
* Family history of arteriopathy other than FMD, SCAD or CvAD (e.g. Ehlers-Danlos syndrome)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes