Clinical trial Recruiting at 1 site Observational Ages 18 and up

Understanding Fibromuscular Dysplasia and Related Arteriopathies

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

Run by Icahn School of Medicine at Mount Sinai · NCT01967511 · Data updated 2026-11-12

This study is trying to collect samples from people with Fibromuscular Dysplasia and related conditions to see what genes might be involved in these diseases.

More Spontaneous Coronary Artery Dissection trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment600 (estimated)
SponsorIcahn School of Medicine at Mount Sinai
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedOctober 1, 2013
Main results expectedDecember 2030
Study endsDecember 2030
Registry record updatedJune 24, 2026
Trial IDNCT01967511 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals of any age with a clinical diagnosis of FMD, SCAD, or CvAD, as well as healthy controls matched by gender and age.

Probably not a fit

Patients with co-morbidities that significantly reduce life expectancy or those with solid organ or hematological transplants may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to establish a comprehensive library of biological samples from patients diagnosed with Fibromuscular Dysplasia (FMD), Spontaneous Coronary Artery Dissection (SCAD), and Cervical Artery Dissection (CvAD), alongside healthy control subjects. The study will conduct a cross-tissue systems genetics analysis to identify key regulatory gene networks and disease drivers associated with these conditions. By comparing the molecular and genomic profiles of these disorders, the research seeks to uncover the underlying biological mechanisms that contribute to their development.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of the biological mechanisms behind FMD and related conditions, potentially improving diagnosis and treatment options for patients.

How similar studies have gone: While this study builds on existing knowledge of FMD and related conditions, its comprehensive cross-tissue analysis approach is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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)

Where it's running

  • Icahn School of Medicine at Mount Sinai
    New York, New York, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.