Last updated on April 2011

SmartRisk Stroke Prediction by MRI of Carotid Disease


Brief description of study

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 or stroke-related events due to carotid plaque within a high-risk population. The SmartRisk software module operates on magnetic resonance images (MRI) of the carotid artery wall.

Detailed Study 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% narrowing) typically do not undergo intervention because the procedural risks outweigh the benefits. However, some of these individuals will have vulnerable plaque that places them at high risk of stroke, but current diagnostic techniques for vulnerable plaque are lacking. Recently, VPDiagnostics developed a new module - SmartRisk - that stratifies risk of stroke for stenotic (50-79% blockage) atherosclerotic plaque. The SmartRisk module uses MRI data to compute a risk assessment from a specific atherosclerotic plaque. A continuous risk value is generated and patients with risk values above a prespecified threshold are at elevated risk for cerebrovascular events arising from carotid artery disease. The purpose of this trial is to determine whether the SmartRisk module is effective at stratifying risk of a carotid-related cerebrovascular event in subjects with asymptomatic 50-79% carotid stenosis.

Clinical Study Identifier: NCT00860184

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Raymond Q Migrino, MD

Carl T. Hayden Medical Research Foundation
Phoenix, AZ United States
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Prediman K Shah, MD

Cedars-Sinai Medical Center
Los Angeles, CA United States
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David Saloner, PhD

University of California San Francisco
San Francisco, CA United States
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Tatjana Rundek, MD

University of Miami
Miami, FL United States
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Richard A Bernstein, MD

Northwestern University
Chicago, IL United States
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Robert Greenman, PhD

Beth Israel Deaconess Medical Center
Boston, MA United States
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Kent Yucel, MD

Tufts Medical Center
Boston, MA United States
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Kumar Rajamani, MD

Wayne State University
Detroit, MI United States
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Kevin DeMarco, MD

Michigan State University
East Lansing, MI United States
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Cezar S Stanilaoe, MD

Gotham Cardiovascular Research PC
New York, NY United States
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Thomas Riles, MD

New York University School of Medicine
New York, NY United States
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Joel Morrisett, PhD

Baylor College of Medicine
Houston, TX United States
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Gerald Treiman, MD

Western Institute for Biomedical Research
Salt Lake City, UT United States
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Xueqiao Zhao, MD

University of Washington
Seattle, WA United States
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Bob L Hou, PhD

West Virginia University
Morgantown, WV United States
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