View Clinical Trial (Medical Research Study)
Assessment of MRI-based Prediction of Stroke and Other Cerebrovascular Symptoms Arising From Carotid Atherosclerotic Disease in Asymptomatic Individuals
| City: |
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Morgantown |
| State: |
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West Virginia |
| Zip Code: |
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26506 |
| Conditions: |
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Atherosclerotic Disease, Carotid |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| 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
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| NCT ID: |
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NCT00860184 |
| Primary Contact: |
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Principal Investigator
William S Kerwin, PhD
VPDiagnostics
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| Backup Contact: |
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N/A |
| Location Contact: |
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Morgantown, West Virginia 26506
United States
Bob L Hou, PhD
Phone: 304-293-1877
Email: bhou@hsc.wvu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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