Recruiting

Fibromuscular Dysplasia

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT01967511

Conditions

Fibromuscular Dysplasia

Spontaneous Coronary Artery Dissection

Cervical Artery Dissection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Fibromuscular Dysplasia

Spontaneous Coronary Artery Dissection

Cervical Artery Dissection

Study ID

NCT01967511

Start date

Oct 1, 2013

Status verified date

Jun, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jason Kovacic, MD, PhD

212-241-7014jason.kovacic@mountsinai.org

Jeffrey Olin, DO

jeffrey.olin@mountsinai.org

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Annette King, ANP

(212) 241-9454annette.king@mountsinai.org

Principal Investigator:

Jason Kovacic, MD, PhD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • Cross-sectional study
  • Fibromuscular dysplasia
  • Fibroblast
  • Spontaneous Coronary Artery Dissection
  • Cervical Artery Dissection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-06-24.