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

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ClinicalTrials.gov Identifier: NCT01272843
Recruitment Status : Unknown
Verified December 2010 by Sunnybrook Health Sciences Centre.
Recruitment status was:  Not yet recruiting
First Posted : January 10, 2011
Last Update Posted : January 10, 2011
Sponsor:
Information provided by:
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.

Condition or disease
Carotid Stenosis Hypoperfusion Transient Ischemic Attack

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2011
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : January 2015

Group/Cohort
Carotid endarterectomy patients
Lumbar stenosis laminectomy patients



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. [ Time Frame: 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. [ Time Frame: Pre-operatively, 3 months post-operatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: December 2010

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