SmartRisk Stroke Prediction by MRI of Carotid Disease - Full Text View

Sponsors and Collaborators:	VPDiagnostics National Institutes of Health (NIH)
Information provided by:	VPDiagnostics
ClinicalTrials.gov Identifier:	NCT00860184

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	300
Study Start Date:	March 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (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. However, subjects with moderate, asymptomatic stenosis (50-79% narrowing) typically do not undergo intervention because the procedural risks outweigh the benefits. 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 12 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

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

Sponsors and Collaborators

VPDiagnostics

National Institutes of Health (NIH)

Investigators

Principal Investigator:

William S Kerwin, PhD

VPDiagnostics

More Information

Additional Information:

study sponsor This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	VPDiagnostics, Inc. ( William Kerwin / Vice President of Research and Development )
Study ID Numbers:	VPD2008A, 5R44 HL070576-05
Study First Received:	March 11, 2009
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00860184 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by VPDiagnostics:

carotid artery
atherosclerosis
stroke
transient ischemic attack

MRI
software
risk

Study placed in the following topic categories:

Atherosclerosis
Ischemic Attack, Transient
Cerebral Infarction
Stroke
Vascular Diseases

Central Nervous System Diseases
Ischemia
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Cardiovascular Diseases

Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on May 07, 2009