Defining the Basis of Fibromuscular Dysplasia: The Define-FMD Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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).

Locations
United States
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Contact Information
Primary
Jason Kovacic, MD, PhD
jason.kovacic@mountsinai.org
212-241-7014
Backup
Jeffrey Olin, DO
jeffrey.olin@mountsinai.org
Time Frame
Start Date: 2013-10
Estimated Completion Date: 2030-12
Participants
Target number of participants: 600
Treatments
FMD subjects
patients who fulfill standard diagnostic criteria for FMD
SCAD subjects
patients who fulfill standard diagnostic criteria for SCAD
CvAD subjects
patients who fulfill standard diagnostic criteria for CvAD
Healthy control subjects
Related Therapeutic Areas
Sponsors
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov