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

March 11, 2009
April 13, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00860184 on ClinicalTrials.gov Archive Site
any cardiovascular event (e.g. MI) [ Time Frame: 18 month mean follow-up at 6 month intervals ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patient referred for ultrasound assessment of carotid artery disease

Atherosclerotic Disease, Carotid
Not Provided
50-79% stenosis
Subjects with 50-79% stenosis of the carotid artery Absence of prior ischemic neurological symptoms Age 18 or older
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
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
Both
18 Years and older
No
Not Provided
United States
 
NCT00860184
VPD2008A, 5R44 HL070576-05
Yes
William Kerwin / Vice President of Research and Development, VPDiagnostics, Inc.
VPDiagnostics
National Institutes of Health (NIH)
Principal Investigator: William S Kerwin, PhD VPDiagnostics
VPDiagnostics
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP