SmartRisk Stroke Prediction by MRI of Carotid Disease

• Conditions: Atherosclerotic Disease, Carotid

• Registration Number: NCT00860184
• Lead Sponsor: VPDiagnostics

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.

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 Timeline

• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Study Start: 2009-11
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-13
• Last Update Posted: 2011-04-14
• Primary Completion: 2012-08
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
stroke or other cerebrovascular symptom (e.g. TIA)	18 month mean follow-up at 6 month intervals

Secondary Outcome Measures

Name	Time	Method
any cardiovascular event (e.g. MI)	18 month mean follow-up at 6 month intervals

Trial Locations

Locations (15)

New York University School of Medicine; 🇺🇸 New York, New York, United States

Gotham Cardiovascular Research PC; 🇺🇸 New York, New York, United States

Michigan State University; 🇺🇸 East Lansing, Michigan, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Carl T. Hayden Medical Research Foundation; 🇺🇸 Phoenix, Arizona, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Western Institute for Biomedical Research; 🇺🇸 Salt Lake City, Utah, United States

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States