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| Sponsor: | VPDiagnostics |
|---|---|
| Collaborator: |
National Institutes of Health (NIH) |
| Information provided by: | VPDiagnostics |
| ClinicalTrials.gov Identifier: | NCT00860184 |
Purpose
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.
| Condition |
|---|
|
Atherosclerotic Disease, Carotid |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Assessment of MRI-based Prediction of Stroke and Other Cerebrovascular Symptoms Arising From Carotid Atherosclerotic Disease in Asymptomatic Individuals |
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
50-79% stenosis
Subjects with 50-79% stenosis of the carotid artery Absence of prior ischemic neurological symptoms Age 18 or older
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patient referred for ultrasound assessment of carotid artery disease
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Carl T. Hayden Medical Research Foundation | Recruiting |
| Phoenix, Arizona, United States, 85012 | |
| Contact: Raymond Q Migrino, MD raymond.migrino@va.gov | |
| United States, California | |
| Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: Prediman K Shah, MD shahp@cshs.org | |
| University of California San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: David Saloner, PhD saloner@radiology.ucsf.edu | |
| United States, Florida | |
| University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Tatjana Rundek, MD 305-243-7847 trundek@med.miami.edu | |
| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Richard A Bernstein, MD richard.bernstein4@gmail.com | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Robert Greenman, PhD rgreenma@caregroup.harvard.edu | |
| Tufts Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Kent Yucel, MD kyucel@tuftsmedicalcenter.org | |
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Kumar Rajamani, MD krajaman@med.wayne.edu | |
| Michigan State University | Recruiting |
| East Lansing, Michigan, United States, 48824 | |
| Contact: Kevin DeMarco, MD J.DeMarco@radiology.msu.edu | |
| United States, New York | |
| Gotham Cardiovascular Research PC | Recruiting |
| New York, New York, United States, 10001 | |
| Contact: Cezar S Stanilaoe, MD Cezar.Stanilaoe@nyumc.org | |
| New York University School of Medicine | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Thomas Riles, MD Thomas.Riles@nyumc.edu | |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Joel Morrisett, PhD morriset@bcm.tmc.edu | |
| Principal Investigator: Joel Morrisett, PhD | |
| United States, Utah | |
| Western Institute for Biomedical Research | Recruiting |
| Salt Lake City, Utah, United States, 84158 | |
| Contact: Gerald Treiman, MD GSTREIMAN@EARTHLINK.NET | |
| United States, Washington | |
| University of Washington | Not yet recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Xueqiao Zhao, MD xueqiao@u.washington.edu | |
| Principal Investigator: Xueqiao Zhao, MD | |
| United States, West Virginia | |
| West Virginia University | Recruiting |
| Morgantown, West Virginia, United States, 26506 | |
| Contact: Bob L Hou, PhD 304-293-1877 bhou@hsc.wvu.edu | |
| Principal Investigator: | William S Kerwin, PhD | VPDiagnostics |
More Information
| Responsible Party: | William Kerwin / Vice President of Research and Development, VPDiagnostics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00860184 History of Changes |
| Other Study ID Numbers: | VPD2008A, 5R44 HL070576-05 |
| Study First Received: | March 11, 2009 |
| Last Updated: | April 13, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
carotid artery atherosclerosis stroke transient ischemic attack |
MRI software risk |
|
Stroke Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |