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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2010 by Sunnybrook Health Sciences Centre
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01272843
First received: January 6, 2011
Last updated: January 7, 2011
Last verified: December 2010
  Purpose

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
Carotid Stenosis
Hypoperfusion
Transient Ischemic Attack

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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. [ Time Frame: Pre-operative, 3 months post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dynamic intracranial angiography will be correlated with arterial arrival time (AAT) hemodynamic metric calculated from arterial spin labeling (ASL) perfusion MRI. [ Time Frame: Pre-operatively, 3 months post-operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Carotid endarterectomy patients
Lumbar stenosis laminectomy patients

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Atherosclerosis is a major risk factor for ischemic cerebrovascular events such as stroke (Bots, Hoes et al. 1997). Carotid endarterectomy (CEA) and carotid stenting (CAS) are common surgical procedures aimed at reducing stroke risk. For individuals with symptomatic stenosis > 70%, CEA has a higher event-free survival compared to medical therapy (Barnett, Taylor et al. 1998) and is considered highly beneficial treatment (Rothwell, Eliasziw et al. 2003). To date, however, few studies have attempted to relate effects of the surgery to changes in brain physiology and function.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272843

Contacts
Contact: Bradley J MacIntosh, PhD 4164806100 ext 7277 bmac@sri.utoronto.ca

Locations
Canada, Ontario
Sunnybrook Research Institute Not yet recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Bradley J MacIntosh, PhD    4164806100 ext 7277    bmac@sri.utoronto.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
  More Information

Additional Information:
Publications:
Responsible Party: Bradley J MacIntosh, Scientist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01272843     History of Changes
Other Study ID Numbers: CEACOG2011
Study First Received: January 6, 2011
Last Updated: January 7, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Ischemic Attack, Transient
Ischemia
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014