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Search / Trial NCT01967511

Defining the Basis of Fibromuscular Dysplasia (FMD)

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Oct 22, 2013

Trial Information

Current as of August 26, 2025

Recruiting

Keywords

Cross Sectional Study Fibromuscular Dysplasia Fibroblast Spontaneous Coronary Artery Dissection Cervical Artery Dissection

ClinConnect Summary

The clinical trial titled "Defining the Basis of Fibromuscular Dysplasia (FMD)" is studying the underlying biological mechanisms of Fibromuscular Dysplasia and related conditions, such as spontaneous coronary artery dissection (SCAD) and cervical artery dissection (CvAD). The researchers aim to understand how cells from patients with these conditions differ from those of healthy individuals. This study includes people of all ages and genders, and it’s currently looking for participants who have been diagnosed with FMD, SCAD, or CvAD, as well as healthy individuals who do not have these conditions.

If you or your family member are interested in participating, you should be able to speak either English or Spanish and provide signed consent. Healthy participants will be matched with those who have been diagnosed based on age and gender. This means there will be a good balance between the two groups in the study. Participants can expect to contribute to important research that could help improve our understanding of these vascular conditions. Additionally, individuals with certain health issues, such as serious ongoing diseases or prior organ transplants, may not be eligible to join. Overall, this trial seeks to gather valuable information that could lead to better treatments and outcomes for those affected by FMD and similar disorders.

Gender

ALL

Eligibility 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)

About Icahn School Of Medicine At Mount Sinai

The Icahn School of Medicine at Mount Sinai is a premier academic institution located in New York City, renowned for its commitment to advancing medical research, education, and patient care. As a leading sponsor of clinical trials, the institution leverages its state-of-the-art facilities and multidisciplinary expertise to drive innovative research initiatives aimed at improving health outcomes. With a focus on translational medicine, the Icahn School of Medicine collaborates with a diverse network of researchers, clinicians, and industry partners to explore novel therapies and interventions across a wide range of medical disciplines. Its rigorous scientific approach and dedication to ethical standards position it as a trusted leader in the clinical research landscape.

Locations

New York, New York, United States

Patients applied

NW

1 patients applied

Trial Officials

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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