Status:
UNKNOWN
SmartRisk Stroke Prediction by MRI of Carotid Disease
Lead Sponsor:
VPDiagnostics
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Atherosclerotic Disease, Carotid
Eligibility:
All Genders
18+ years
Brief Summary
Atherosclerotic plaque at the carotid artery bifurcation is a major source of stroke. The purpose of this investigation is to determine the ability of the SmartRisk software module to predict stroke o...
Detailed Description
Carotid artery disease (atherosclerosis) is a major cause of stroke that can be treated with carotid endarterectomy surgery (CEA) or stenting. Subjects with moderate, asymptomatic stenosis (50-79% nar...
Eligibility Criteria
Inclusion
- 50-79% stenosis of the carotid artery
- age 18 or older
- no ischemic neurovascular symptoms within preceding 6 months
Exclusion
- contraindication to MRI (e.g. weight \> 130 kg, pregnancy)
- prior or planned carotid endarterectomy or stenting
- history of atrial fibrillation
- prior neck irradiation
Key Trial Info
Start Date :
November 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2012
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00860184
Start Date
November 1 2009
End Date
August 1 2012
Last Update
April 14 2011
Active Locations (15)
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1
Carl T. Hayden Medical Research Foundation
Phoenix, Arizona, United States, 85012
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
University of California San Francisco
San Francisco, California, United States, 94143
4
University of Miami
Miami, Florida, United States, 33136