Defining the Basis of Fibromuscular Dysplasia (FMD) — DEFINE  

Spontaneous Coronary Artery Dissection Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Specific aims

• Specific aim 1: To establish a library of fibroblasts, DNA, plasma and serum from patients with FMD, SCAD and CvAD and unaffected healthy control subjects.

• Specific aim 2: To perform a fully powered cross-tissue systems analysis of the key regulatory gene networks and disease drivers underlying FMD, SCAD and CvAD.

• Specific aim 3: To cross-compare the molecular and genomic profiles of FMD, SCAD and CvAD to establish the degree of biologic similarity among these disorders. ;

Related Conditions & MeSH terms

• Aortic Dissection
• Cervical Artery Dissection
• Coronary Vessel Anomalies
• Fibromuscular Dysplasia
• Hyperplasia
• Spontaneous Coronary Artery Dissection
• Vascular Diseases

• NCT number: NCT01967511
• Study type: Observational
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Jason Kovacic, MD, PhD
• Phone: 212-241-7014
• Email: jason.kovacic@mountsinai.org
• Status: Recruiting
• Start date: October 2013
• Completion date: December 2025