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

Transient Ischemic Attack Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01272843
• Other study ID #: CEACOG2011
• Status: Not yet recruiting
• Phase: N/A
• First received: January 6, 2011
• Last updated: January 7, 2011
• Start date: February 2011
• Est. completion date: January 2015

Study information

• Verified date: December 2010
• Source: Sunnybrook Health Sciences Centre
• Contact: Bradley J MacIntosh, PhD
• Phone: 4164806100
• Email: bmac[@]sri.utoronto.ca
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carotid Stenosis
• Hypoperfusion
• Ischemic Attack, Transient
• Transient Ischemic Attack

Locations

Country	Name	City	State
Canada	Sunnybrook Research Institute	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (3)

MacIntosh BJ, Filippini N, Chappell MA, Woolrich MW, Mackay CE, Jezzard P. Assessment of arterial arrival times derived from multiple inversion time pulsed arterial spin labeling MRI. Magn Reson Med. 2010 Mar;63(3):641-7. doi: 10.1002/mrm.22256. — View Citation

MacIntosh BJ, Lindsay AC, Kylintireas I, Kuker W, Günther M, Robson MD, Kennedy J, Choudhury RP, Jezzard P. Multiple inflow pulsed arterial spin-labeling reveals delays in the arterial arrival time in minor stroke and transient ischemic attack. AJNR Am J — View Citation

MacIntosh BJ, McIlroy WE, Mraz R, Staines WR, Black SE, Graham SJ. Electrodermal recording and fMRI to inform sensorimotor recovery in stroke patients. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):728-36. doi: 10.1177/1545968308316386. Epub 2008 Sep 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Heart and Stroke Foundation Centre for Stroke Recovery
•   Sunnybrook Research website