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Physiological Magnetic Resonance Imaging (MRI) to Improve Carotid Endarterectomy Outcomes

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Unknown status
CT.gov ID
NCT01272843
Collaborator
(none)
50
Enrollment
1
Location
47
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The carotid arteries are blood vessels in the neck that supply blood to the brain. Carotid stenosis disease is defined as a narrowing of these arteries due to the build up of plaque. The plaque material can also break off and move into the brain. The resulting blockage of blood supply to a portion of the brain is what causes 80% of all strokes. One treatment option is to have surgery on the carotid artery and remove the plaque. This procedure is called a carotid endarterectomy (CEA). There is evidence that proves CEA reduces the risk of stroke. The objective of this research project is to determine who is most likely to benefit from CEA surgery.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Feb 1, 2011
    Anticipated Primary Completion Date :
    Mar 1, 2014
    Anticipated Study Completion Date :
    Jan 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Carotid endarterectomy patients
    Lumbar stenosis laminectomy patients

    Outcome Measures

    Primary Outcome Measures

    1. Functional MRI (fMRI) results will be used to calculate the activation-related hemodynamic response function (HRF) in patients undergoing carotid endarterectomy, which will be significantly reduced post-operative at 3 months follow-up. [Pre-operative, 3 months post-operative]

    Secondary Outcome Measures

    1. Dynamic intracranial angiography will be correlated with arterial arrival time (AAT) hemodynamic metric calculated from arterial spin labeling (ASL) perfusion MRI. [Pre-operatively, 3 months post-operatively]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Greater than 30 years of age

    • Greater than grade 9 education level

    • Mini-mental state exam (MMSE) greater than 19 for carotid stenosis patients

    Exclusion Criteria:

    • History of acute stroke

    • History of current psychiatric disorder, such as depression or movement disorder

    • Diagnosed Alzheimer's Disease or dementia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sunnybrook Research Institute Toronto Ontario Canada M4N3M5

    Sponsors and Collaborators

    • Sunnybrook Health Sciences Centre

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01272843
    Other Study ID Numbers:
    • CEACOG2011
    First Posted:
    Jan 10, 2011
    Last Update Posted:
    Jan 10, 2011
    Last Verified:
    Dec 1, 2010
    Additional relevant MeSH terms:
    Ischemic Attack, Transient
    Carotid Stenosis

    Study Results

    No Results Posted as of Jan 10, 2011