Clinical trial NCT00860184: SmartRisk Stroke Prediction by MRI of Carotid Disease
Official title: Assessment of MRI-based Prediction of Stroke and Other Cerebrovascular Symptoms Arising From Carotid Atherosclerotic Disease in Asymptomatic Individuals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerotic Disease, Carotid
Keywords: carotid artery
atherosclerosis
stroke
transient ischemic attack
MRI
software
risk
Lead sponsor: VPDiagnostics
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-03-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient referred for ultrasound assessment of carotid artery disease

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.

Eligibility 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

Primary outcomes:
measure: stroke or other cerebrovascular symptom (e.g. TIA)
timeFrame: 18 month mean follow-up at 6 month intervals
Secondary outcomes:
measure: any cardiovascular event (e.g. MI)
timeFrame: 18 month mean follow-up at 6 month intervals
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Carl T. Hayden Medical Research Foundation
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: New York
country: United States
facility: Gotham Cardiovascular Research PC
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: Western Institute for Biomedical Research
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: VPDiagnostics
name: William S Kerwin, PhD
role: PRINCIPAL_INVESTIGATOR
References: