Defining the Basis of Fibromuscular Dysplasia (FMD)

Recruiting

• Conditions: Fibromuscular Dysplasia; Spontaneous Coronary Artery Dissection; Cervical Artery Dissection

• Registration Number: NCT01967511
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-18
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients of any age and freely willing to participate. For patients < 18 years of<br> age consent will be via parents.<br><br> - Fluency in either English or Spanish.<br><br> - Signed, informed consent<br><br> - For FMD, SCAD or CvAD subjects - a clinical diagnosis of FMD, SCAD or CvAD with<br> fulfillment of standard diagnostic criteria.<br><br> - For healthy controls - no clinical features of FMD, SCAD or CvAD and absence of any<br> major ongoing systemic disease including any condition requiring hospitalization,<br> immune suppression, intravenous or injected medications or that result in functional<br> impairment in the performance of activities of daily living. Healthy controls will<br> be matched to enrolled FMD patients on the basis of gender and approximate age<br> (within a 5 year window of another FMD subject).<br><br>Exclusion Criteria:<br><br> - Patients who have co-morbidities which reduces life expectancy to one year.<br><br> - Patients with any solid organ or hematological transplantation, or those in whom<br> transplantation is considered.<br><br> - Active autoimmune disease.<br><br> - Illicit drug use.<br><br> - HIV positive.<br><br> - Prior malignancy.<br><br> - Any other form of vascular disease, including other arteriopathy coronary artery<br> disease or peripheral vascular disease<br><br> - Family history of arteriopathy other than FMD, SCAD or CvAD (e.g. Ehlers-Danlos<br> syndrome)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of regulatory gene networks

Secondary Outcome Measures

Name	Time	Method
Identification of molecular features;Identification of genomic features;RNA sequencing;Circulating cytokine