SmartRisk Stroke Prediction by MRI of Carotid Disease

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Atherosclerotic Disease, Carotid

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 50-79% stenosis<br>Subjects with 50-79% stenosis of the carotid artery Absence of prior ischemic neurological symptoms Age 18 or older | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stroke or other cerebrovascular symptom (e.g. TIA) |  | 18 month mean follow-up at 6 month intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any cardiovascular event (e.g. MI) |  | 18 month mean follow-up at 6 month intervals | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carotid artery, atherosclerosis, transient ischemic attack, MRI, software, risk, stroke