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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44HL070576-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50-79% stenosis | Subjects with 50-79% stenosis of the carotid artery Absence of prior ischemic neurological symptoms Age 18 or older |
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| Measure | Description | Time Frame |
|---|---|---|
| stroke or other cerebrovascular symptom (e.g. TIA) | 18 month mean follow-up at 6 month intervals |
| Measure | Description | Time Frame |
|---|---|---|
| any cardiovascular event (e.g. MI) | 18 month mean follow-up at 6 month intervals |
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Inclusion Criteria:
Exclusion Criteria:
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Patient referred for ultrasound assessment of carotid artery disease
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| Name | Affiliation | Role |
|---|---|---|
| William S Kerwin, PhD | VPDiagnostics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carl T. Hayden Medical Research Foundation | Recruiting | Phoenix | Arizona | 85012 | United States |
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| Label | URL |
|---|---|
| VPDiagnostics website | View source |
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| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| University of California San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Wayne State University | Recruiting | Detroit | Michigan | 48201 | United States |
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| Michigan State University | Recruiting | East Lansing | Michigan | 48824 | United States |
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| Gotham Cardiovascular Research PC | Recruiting | New York | New York | 10001 | United States |
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| New York University School of Medicine | Recruiting | New York | New York | 10016 | United States |
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| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| Western Institute for Biomedical Research | Recruiting | Salt Lake City | Utah | 84158 | United States |
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| University of Washington | Not yet recruiting | Seattle | Washington | 98109 | United States |
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| West Virginia University | Recruiting | Morgantown | West Virginia | 26506 | United States |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D050197 | Atherosclerosis |
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D002545 | Brain Ischemia |
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