SmartRisk Stroke Prediction by MRI of Carotid Disease
SmartRisk Stroke Prediction by MRI of Carotid Disease
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