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Understanding Fibromuscular Dysplasia and Related Conditions

This observational study aims to understand the biological causes of Fibromuscular Dysplasia (FMD), Spontaneous Coronary Artery Dissection (SCAD), and Cervical Artery Dissection (CvAD). Researchers are collecting samples like fibroblasts (a type of cell), DNA, plasma, and serum from people with these conditions and healthy volunteers. The goal is to identify key gene networks that drive these disorders and see how similar FMD, SCAD, and CvAD are at a molecular level. This study is looking for 600 participants, aged 18 and older, who have been diagnosed with FMD, SCAD, or CvAD, or are healthy volunteers. Success will be measured by identifying regulatory gene networks at the time you join the study. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 600 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Regulatory gene networks will be measured at a single time point at study enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01967511

Defining the Basis of Fibromuscular Dysplasia (FMD)

Recruiting
Not specifiedAges 18+Observational
Icahn School of Medicine at Mount Sinai
~600 participants
Updated 2026-06-24 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identification of regulatory gene networks
Measured over single time point at study enrollment

Conditions

Fibromuscular Dysplasia
Spontaneous Coronary Artery Dissection
Cervical Artery Dissection

Explore related trials

Cervical artery dissectionFibromuscular DysplasiaSpontaneous Coronary Artery Dissection

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Jason Kovacic, MD, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Jeffrey Olin, DO · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Jason Kovacic, MD, PhD
[email protected]
212-241-7014
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Identification of regulatory gene networkssingle time point at study enrollment

    The identification of regulatory gene networks, and their key drivers, underlying FMD, SCAD and CvAD