SmartRisk Stroke Prediction by MRI of Carotid Disease (SmartRisk)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00860184
Recruitment Status : Unknown
Verified April 2011 by VPDiagnostics.
Recruitment status was:  Recruiting
First Posted : March 12, 2009
Last Update Posted : April 14, 2011
National Institutes of Health (NIH)
Information provided by:

March 11, 2009
March 12, 2009
April 14, 2011
November 2009
August 2012   (Final data collection date for primary outcome measure)
stroke or other cerebrovascular symptom (e.g. TIA) [ Time Frame: 18 month mean follow-up at 6 month intervals ]
Same as current
Complete list of historical versions of study NCT00860184 on Archive Site
any cardiovascular event (e.g. MI) [ Time Frame: 18 month mean follow-up at 6 month intervals ]
Same as current
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SmartRisk Stroke Prediction by MRI of Carotid Disease
Assessment of MRI-based Prediction of Stroke and Other Cerebrovascular Symptoms Arising From Carotid Atherosclerotic Disease in Asymptomatic Individuals
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.
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patient referred for ultrasound assessment of carotid artery disease
Atherosclerotic Disease, Carotid
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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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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
August 2012
August 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
5R44HL070576-05 ( U.S. NIH Grant/Contract )
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William Kerwin / Vice President of Research and Development, VPDiagnostics, Inc.
National Institutes of Health (NIH)
Principal Investigator: William S Kerwin, PhD VPDiagnostics
April 2011