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

• Conditions: Carotid Stenosis; Hypoperfusion; Transient Ischemic Attack

• Registration Number: NCT01272843
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-12
• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-07
• Last Update Submitted: 2011-01-07
• Study First Posted: 2011-01-10
• Last Update Posted: 2011-01-10
• Study Start: 2011-02
• Primary Completion: 2014-03
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Sunnybrook Research Institute; 🇨🇦 Toronto, Ontario, Canada