SmartRisk Stroke Prediction by MRI of Carotid Disease

Atherosclerotic Disease, Carotid Clinical Trial

— SmartRisk  

Official title:

Assessment of MRI-based Prediction of Stroke and Other Cerebrovascular Symptoms Arising From Carotid Atherosclerotic Disease in Asymptomatic Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00860184
• Other study ID #: VPD2008A
• Secondary ID: 5R44HL070576-05
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2009
• Last updated: April 13, 2011
• Start date: November 2009
• Est. completion date: August 2012

Study information

• Verified date: April 2011
• Source: VPDiagnostics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerotic Disease, Carotid
• Carotid Artery Diseases

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Wayne State University	Detroit	Michigan
United States	Michigan State University	East Lansing	Michigan
United States	Baylor College of Medicine	Houston	Texas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	West Virginia University	Morgantown	West Virginia
United States	Gotham Cardiovascular Research PC	New York	New York
United States	New York University School of Medicine	New York	New York
United States	Carl T. Hayden Medical Research Foundation	Phoenix	Arizona
United States	Western Institute for Biomedical Research	Salt Lake City	Utah
United States	University of California San Francisco	San Francisco	California
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
VPDiagnostics	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stroke or other cerebrovascular symptom (e.g. TIA)		18 month mean follow-up at 6 month intervals	No
Secondary	any cardiovascular event (e.g. MI)		18 month mean follow-up at 6 month intervals	No