Assessment of MRI-based Prediction of Stroke and Other Cerebrovascular Symptoms Arising From Carotid Atherosclerotic Disease in Asymptomatic Individuals
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atherosclerotic Disease, Carotid
- Sponsor
- VPDiagnostics
- Enrollment
- 300
- Locations
- 15
- Primary Endpoint
- stroke or other cerebrovascular symptom (e.g. TIA)
- Last Updated
- 15 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
stroke or other cerebrovascular symptom (e.g. TIA)
Time Frame: 18 month mean follow-up at 6 month intervals
Secondary Outcomes
- any cardiovascular event (e.g. MI)(18 month mean follow-up at 6 month intervals)