SmartRisk Stroke Prediction by MRI of Carotid Disease



Status:Completed
Conditions:Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:November 2009
End Date:August 2012

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Assessment of MRI-based Prediction of Stroke and Other Cerebrovascular Symptoms Arising From Carotid Atherosclerotic Disease in Asymptomatic Individuals

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.

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.

Inclusion Criteria:

- 50-79% stenosis of the carotid artery

- age 18 or older

- no ischemic neurovascular symptoms within preceding 6 months

Exclusion Criteria:

- contraindication to MRI (e.g. weight > 130 kg, pregnancy)

- prior or planned carotid endarterectomy or stenting

- history of atrial fibrillation

- prior neck irradiation
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Morgantown, West Virginia 26506
(304) 293-0111
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330 Brookline Ave
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
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1200 Moursund Street
Houston, Texas 77030
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8700 Beverly Blvd # 8211
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Miami, Florida 33124
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Seattle, Washington 98104
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303 East Superior Street
Chicago, Illinois 60611
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East Lansing, Michigan 48824
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New York, New York 10001
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(212) 263-7300
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Salt Lake City, Utah 84158
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