Defining the Basis of Fibromuscular Dysplasia (FMD)

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT01967511
Status
Recruiting

Conditions

  • Cervical Artery Dissection
  • Fibromuscular Dysplasia
  • Spontaneous Coronary Artery Dissection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Oct 31, 2013
Status verified
Sep 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: FMD subjects
    patients who fulfill standard diagnostic criteria for FMD
  • Arm: SCAD subjects
    patients who fulfill standard diagnostic criteria for SCAD
  • Arm: CvAD subjects
    patients who fulfill standard diagnostic criteria for CvAD
  • Arm: Healthy control subjects

Primary Outcome Measure

Identification of regulatory gene networks [ Time Frame: single time point at study enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Annette King, ANP
212-241-9454
Jason Kovacic, MD, PhD (PRINCIPAL_INVESTIGATOR)

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