Defining the Basis of Fibromuscular Dysplasia (FMD) (DEFINE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01967511|
Recruitment Status : Recruiting
First Posted : October 23, 2013
Last Update Posted : June 8, 2017
|Condition or disease|
|Fibromuscular Dysplasia Spontaneous Coronary Artery Dissection Cervical Artery Dissection|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Defining the Basis of Fibromuscular Dysplasia: The Define-FMD Study|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
patients who fulfill standard diagnostic criteria for FMD
patients who fulfill standard diagnostic criteria for SCAD
patients who fulfill standard diagnostic criteria for CvAD
|Healthy control subjects|
- Identification of regulatory gene networks [ Time Frame: single time point at study enrollment ]The identification of regulatory gene networks, and their key drivers, underlying FMD, SCAD and CvAD
- Identification of molecular features [ Time Frame: single time point at study enrollment ]To cross-compare the molecular features of FMD, SCAD and CvAD
- Identification of genomic features [ Time Frame: single time point at study enrollment ]To cross-compare the genomic features of FMD, SCAD and CvAD
- RNA sequencing [ Time Frame: single time point at study enrollment ]To define and compare the genomic (RNA sequencing) profile of fibroblasts from FMD, SCAD and CvAD subjects versus healthy control subjects
- Circulating cytokine [ Time Frame: single time point at study enrollment ]To define and compare the circulating cytokine profile of FMD versus healthy control subjects.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967511
|Contact: Jason Kovacic, MD, PhDfirstname.lastname@example.org|
|Contact: Jeffrey Olin, DOemail@example.com|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Annette King, ANP 212-241-9454 firstname.lastname@example.org|
|Principal Investigator: Jason Kovacic, MD, PhD|
|Principal Investigator:||Jason Kovacic, MD, PhD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Jeffrey Olin, DO||Icahn School of Medicine at Mount Sinai|