Defining the Basis of Fibromuscular Dysplasia (FMD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Will enroll 200 FMD patients, 100 SCAD patients, and 100 CvAD patients at the Mount Sinai Hospital. 200 matched healthy controls will also be recruited to this study.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 4 trial groupsGroup A: FMD subjects
Group B: SCAD subjects
Group C: CvAD subjects
Group D: Healthy control subjects
Trial outcomes
Primary outcomes
1
Identification of regulatory gene networks
The identification of regulatory gene networks, and their key drivers, underlying FMD, SCAD and CvAD
Time frame
single time point at study enrollmentSecondary outcomes
1
Identification of molecular features
To cross-compare the molecular features of FMD, SCAD and CvAD
Time frame
single time point at study enrollment2
Identification of genomic features
To cross-compare the genomic features of FMD, SCAD and CvAD
Time frame
single time point at study enrollment3
RNA sequencing
To define and compare the genomic (RNA sequencing) profile of fibroblasts from FMD, SCAD and CvAD subjects versus healthy control subjects
Time frame
single time point at study enrollment4
Circulating cytokine
To define and compare the circulating cytokine profile of FMD versus healthy control subjects.
Time frame
single time point at study enrollmentSponsors and contacts
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Source ClinicalTrials.gov