SmartRisk Stroke Prediction by MRI of Carotid Disease

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