SmartRisk Stroke Prediction by MRI of Carotid Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by VPDiagnostics.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
VPDiagnostics
ClinicalTrials.gov Identifier:
NCT00860184
First received: March 11, 2009
Last updated: April 13, 2011
Last verified: April 2011
  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

Further study details as provided by VPDiagnostics:

Primary Outcome Measures:
  • stroke or other cerebrovascular symptom (e.g. TIA) [ Time Frame: 18 month mean follow-up at 6 month intervals ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • any cardiovascular event (e.g. MI) [ Time Frame: 18 month mean follow-up at 6 month intervals ] [ Designated as safety issue: No ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient referred for ultrasound assessment of carotid artery disease

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860184

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   
Sponsors and Collaborators
VPDiagnostics
Investigators
Principal Investigator: William S Kerwin, PhD VPDiagnostics
  More Information

Additional Information:
No publications provided

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

Keywords provided by VPDiagnostics:
carotid artery
atherosclerosis
stroke
transient ischemic attack
MRI
software
risk

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

ClinicalTrials.gov processed this record on September 18, 2014