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:

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.

Condition or disease
Atherosclerotic Disease, Carotid

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.

Study Type : Observational
Estimated Enrollment : 300 participants
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
Study Start Date : November 2009
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

50-79% stenosis
Subjects with 50-79% stenosis of the carotid artery Absence of prior ischemic neurological symptoms Age 18 or older

Primary Outcome Measures :
  1. stroke or other cerebrovascular symptom (e.g. TIA) [ Time Frame: 18 month mean follow-up at 6 month intervals ]

Secondary Outcome Measures :
  1. any cardiovascular event (e.g. MI) [ Time Frame: 18 month mean follow-up at 6 month intervals ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient referred for ultrasound assessment of carotid artery disease

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00860184

United States, Arizona
Carl T. Hayden Medical Research Foundation Recruiting
Phoenix, Arizona, United States, 85012
Contact: Raymond Q Migrino, MD   
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Prediman K Shah, MD   
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: David Saloner, PhD   
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Tatjana Rundek, MD    305-243-7847   
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Richard A Bernstein, MD   
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Kent Yucel, MD   
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Robert Greenman, PhD   
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Kumar Rajamani, MD   
Michigan State University Recruiting
East Lansing, Michigan, United States, 48824
Contact: Kevin DeMarco, MD   
United States, New York
Gotham Cardiovascular Research PC Recruiting
New York, New York, United States, 10001
Contact: Cezar S Stanilaoe, MD   
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Thomas Riles, MD   
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Joel Morrisett, PhD   
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   
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   
Sponsors and Collaborators
National Institutes of Health (NIH)
Principal Investigator: William S Kerwin, PhD VPDiagnostics

Additional Information:
Responsible Party: William Kerwin / Vice President of Research and Development, VPDiagnostics, Inc. Identifier: NCT00860184     History of Changes
Other Study ID Numbers: VPD2008A
5R44HL070576-05 ( U.S. NIH Grant/Contract )
First Posted: March 12, 2009    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: April 2011

Keywords provided by VPDiagnostics:
carotid artery
transient ischemic attack

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases