Carotid StenosisNCT01272843
Physiological Magnetic Resonance Imaging (MRI) to Improve Carotid Endarterectomy Outcomes
An observational study of Carotid Stenosis and Hypoperfusion, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Carotid Stenosis, Hypoperfusion, Transient Ischemic Attack
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Greater than 30 years of age
- Greater than grade 9 education level
- Mini-mental state exam (MMSE) greater than 19 for carotid stenosis patients
Who cannot join
- History of acute stroke
- History of current psychiatric disorder, such as depression or movement disorder
- Diagnosed Alzheimer's Disease or dementia
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Research Institute
Toronto, Ontario, M4N3M5
Bradley J MacIntosh, PhD, 4164806100 ext. 7277, bmac@sri.utoronto.ca
About this study
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.
- Conditions
- Carotid Stenosis, Hypoperfusion, Transient Ischemic Attack
- Medical subject headings
- Carotid Stenosis, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Carotid endarterectomy patients | Not described | |
| Lumbar stenosis laminectomy patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre-operatively, 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272843
- Sponsor's protocol ID
- CEACOG2011
- Status last verified
- Dec 2010
- First submitted
- 6 Jan 2011
- Last updated
- 10 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20146233MacIntosh 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.
PubMed 20110375MacIntosh 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.
PubMed 18784267
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Magnetic Resonance Imaging (MRI) to Improve Carotid Endarterectomy Outcomes
- ClinicalTrials.gov ID
- NCT01272843
- Acronym / sponsor ID
- CEACOG2011
- Conditions
- Carotid Stenosis, Hypoperfusion, Transient Ischemic Attack
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 10 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotid endarterectomy patients | – | – |
| Lumbar stenosis laminectomy patients | – | – |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Greater than 30 years of age
- Greater than grade 9 education level
- Mini-mental state exam (MMSE) greater than 19 for carotid stenosis patients
Key exclusion criteria (3 listed)
- History of acute stroke
- History of current psychiatric disorder, such as depression or movement disorder
- Diagnosed Alzheimer's Disease or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2011.
- Results publication: PubMed 20146233MacIntosh 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.
- Results publication: PubMed 20110375MacIntosh 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.
- Results publication: PubMed 18784267MacIntosh 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.
- Sunnybrook Research websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Stenosis and Hypoperfusion, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bradley J MacIntosh, PhD (4164806100 ext. 7277, bmac@sri.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01272843, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2011.