NCT01272843

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 10, 2011

Status Verified

December 1, 2010

Enrollment Period

3.1 years

First QC Date

January 6, 2011

Last Update Submit

January 7, 2011

Conditions

Carotid StenosisHypoperfusionTransient Ischemic Attack

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (2)

Carotid endarterectomy patients

Lumbar stenosis laminectomy patients

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Greater than 30 years of age
  • Greater than grade 9 education level
  • Mini-mental state exam (MMSE) greater than 19 for carotid stenosis patients

You may not qualify if:

  • History of acute stroke
  • History of current psychiatric disorder, such as depression or movement disorder
  • Diagnosed Alzheimer's Disease or dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Research Institute

Toronto, Ontario, M4N3M5, Canada

Location

Related 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.

    PMID: 20146233RESULT

  • MacIntosh BJ, Lindsay AC, Kylintireas I, Kuker W, Gunther 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 Neuroradiol. 2010 Nov;31(10):1892-4. doi: 10.3174/ajnr.A2008. Epub 2010 Jan 28.

    PMID: 20110375RESULT

  • 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.

    PMID: 18784267RESULT

Related Links

MeSH Terms

Conditions

Carotid StenosisIschemic Attack, Transient

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Central Study Contacts

Bradley J MacIntosh, PhD

CONTACT

4164806100bmac@sri.utoronto.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2011

First Posted

January 10, 2011

Study Start

February 1, 2011

Primary Completion

March 1, 2014

Study Completion

January 1, 2015

Last Updated

January 10, 2011

Record last verified: 2010-12

Locations

CA(1)