Cognition And Neocortical Volume After Stroke (CANVAS)
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ClinicalTrials.gov Identifier: NCT02205424 |
Recruitment Status :
Completed
First Posted : July 31, 2014
Last Update Posted : June 10, 2022
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Condition or disease |
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Ischaemic Stroke Alzheimer's Disease Vascular Dementia |
Our primary outcome measure was total brain volume (TBV) change between the 3-month and 3-year time-points compared between stroke patients and controls.
Secondary outcome 1 was TBV change between 3-months and 3-years comparing CN and CI stroke participants. TBV at 3-months will be adjusted for CCI scores, and years of education; the latter as it is correlated with cognitive performance and post-stroke dementia risk, but not for stroke lesion volume as no conclusive evidence for an effect has been demonstrated previously.
Secondary outcome 2 was hippocampal volume (HV) change between 3-months and 3-years in stroke patients and controls with adjustments identical to primary outcome.
Secondary outcome 3 was the comparison of HV change between 3-months and 3-years comparing CN and CI stroke participants with adjustments identical to secondary outcome 1.
See published protocol and uploaded statistical analysis plan for detailed description.
Study Type : | Observational |
Actual Enrollment : | 175 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Is Stroke Neurodegenerative? A Longitudinal Study of Brain Volume and Cognitive Decline Following Stroke (CANVAS: Cognition And Neocortical Volume After Stroke). |
Actual Study Start Date : | May 1, 2011 |
Actual Primary Completion Date : | December 31, 2020 |
Actual Study Completion Date : | June 30, 2021 |

Group/Cohort |
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Ischaemic stroke patients
Patients who have suffered an ischaemic stroke, as determined clinically and verified with imaging (CT brain; MRI).
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Healthy control participants
People who have never suffered a stroke, and are matched to the ischaemic stroke patient group according to age, education, and vascular risk factors.
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- Difference in total brain volume between 3 month and 3 year time-points [ Time Frame: Between 3 months and 3 years post-stroke ]We will examine changes in brain volume between the 3 month and 3 year time-points in ischemic stroke patients and healthy age-matched control participants
- Comparison of total brain volume (TBV) change between 3 month and 3 year time-points in those who were cognitively normal (CN) versus cognitively impaired (CI) determined at the 3 months post-stroke time point. [ Time Frame: Between 3 months and 3 years post-stroke ]Secondary outcome 1 was TBV change between 3-months and 3-years comparing CN and CI stroke participants.
- Difference in hippocampal volume between 3 month and 3 year time-points in stroke and control participants. [ Time Frame: Between 3 months and 3 years post-stroke ]Secondary outcome 2 was hippocampal volume (HV) change between 3-months and 3-years in stroke patients and controls with adjustments identical to primary outcome.
- Comparison of hippocampal volume change between 3 month and 3 year time-points in those who were cognitively normal versus cognitively impaired at 3 months post-stroke. [ Time Frame: Between 3 months and 3 years post-stroke ]Secondary outcome 3 was the comparison of HV change between 3-months and 3-years comparing CN and CI stroke participants with adjustments identical to secondary outcome 1.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Clinical stroke
- Aged greater than 18 years;
- Able to have cognitive testing and MRI scan; and
- Able to give informed consent
Exclusion Criteria:
- Significant medical comorbidities precluding participation in cognitive testing, or making survival for three years unlikely;
- Normal exclusion criteria for MRI; e.g., implanted metal, severe claustrophobia;
- Pre-existing dementia
- Pregnancy, as a precaution to prevent exposing them to multiple MRI scans in a 12-month period
- People in existing dependent or unequal relationships with any member of the research team, to protect against coercion

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): NCT02205424
Australia, Victoria | |
Eastern Health | |
Box Hill, Victoria, Australia, 3128 | |
Austin Health | |
Heidelberg, Victoria, Australia, 3084 | |
Melbourne Health | |
Parkville, Victoria, Australia, 3050 |
Principal Investigator: | Amy G Brodtmann, MBBS PhD | The Florey Institute of Neuroscience and Mental Health |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Amy Brodtmann, Prof Amy Brodtmann, The Florey Institute of Neuroscience and Mental Health |
ClinicalTrials.gov Identifier: | NCT02205424 |
Other Study ID Numbers: |
APP-1020526 |
First Posted: | July 31, 2014 Key Record Dates |
Last Update Posted: | June 10, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Ischaemic stroke Alzheimer's disease Brain volume Cortical thickness Magnetic Resonance Imaging |
Stroke Alzheimer Disease Ischemic Stroke Dementia, Vascular Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Dementia Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Intracranial Arteriosclerosis Intracranial Arterial Diseases Leukoencephalopathies Arteriosclerosis Arterial Occlusive Diseases |