Arterial Occlusive Disease Clinical Trial
Official title:
Imaging of Plaque in Atherosclerosis With Intravascular MRI
Verified date | July 2015 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This study aims to develop and refine the use of an intravascular wire to image plaque in
the aorta, iliac and femoral artery using MRI. This project aims to use this increased
resolution to identify the features within the plaque that is known to be associated with
increased risk of plaque and vessel occlusion.
The hypothesis is Intravascular MRI can detect and measure changes in response to therapy
over time in the critical features in plaques in peripheral arteries of patients with
atherosclerosis.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 2005 |
Est. primary completion date | June 2005 |
Accepts healthy volunteers | |
Gender | Both |
Age group | 25 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Male and female adults (aged 25-80) seen at the Brigham and Women's Hospital (BWH) clinic who have known arterial disease who consent to cannulation of the femoral artery for this research. - Patients in the prespecified age group who are scheduled to undergo a clinically indicated heart or peripheral catheterization at the BWH catheterization (cath) lab who will have a tube (sheath) already positioned in their femoral artery - Patient must be in stable condition with regard to symptoms, vital signs and the monitored electrocardiogram Exclusion Criteria: - Unstable symptoms, vital signs or electrocardiogram after the heart cath - Any complications during the heart cath (eg., bleeding, angina, arrhythmias, technical difficulties cannulating the femoral artery) - Creatinine >2.0mg/dl - Pregnancy - Contraindications to anticoagulation - Patients with a metal implant, pacemaker, cardiac defibrillator, metal fragments in the eye, bullets/metal objects in the body |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Womens Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Peter Ganz MD |
United States,
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