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Cognition And Neocortical Volume After Stroke (CANVAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02205424
Recruitment Status : Completed
First Posted : July 31, 2014
Last Update Posted : June 10, 2022
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Amy Brodtmann, The Florey Institute of Neuroscience and Mental Health

Brief Summary:
Stroke and dementia are two of the most common and disabling conditions worldwide, responsible for an enormous and growing burden of disease. There is increasing awareness that the two conditions are linked, with cognitive impairment and dementia common after stroke, vascular dementia accounting for about one-fifth of all dementia cases and recent evidence on the contribution of vascular risk factors to Alzheimer's disease. Yet little is known about whether brain volume loss - a hallmark of dementia - occurs after stroke, and whether such atrophy is related to cognitive decline. The aim of this research is to establish whether stroke patients have reductions in brain volume in the first three years post-stroke compared to control subjects, and whether regional and global brain volume change is associated with post-stroke dementia in order to elucidate potential causal mechanisms (including genetic markers, amyloid deposition and vascular risk factors). The hypotheses are that stroke patients will exhibit greater brain volume loss than comparable cohorts of stroke-free controls, and further, that stroke patients who develop dementia will exhibit greater global and regional brain volume loss than those who do not dement. An understanding of whether stroke is neurodegenerative, and in which patients, may be used to help guide the early delivery of disease-modifying therapies.

Condition or disease
Ischaemic Stroke Alzheimer's Disease Vascular Dementia

Detailed Description:

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Group/Cohort
Ischaemic stroke patients
Patients who have suffered an ischaemic stroke, as determined clinically and verified with imaging (CT brain; MRI).
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Biospecimen Retention:   Samples With DNA
Venous blood for APOE estimation.


Information from the National Library of Medicine

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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
Study Population
Ischaemic stroke patients will have been admitted to the Acute Neurology Units of the Austin Hospital (Heidelberg), Royal Melbourne Hospital (Parkville), and Box Hill Hospital (Box Hill).
Criteria

Inclusion Criteria:

  1. Clinical stroke
  2. Aged greater than 18 years;
  3. Able to have cognitive testing and MRI scan; and
  4. Able to give informed consent

Exclusion Criteria:

  1. Significant medical comorbidities precluding participation in cognitive testing, or making survival for three years unlikely;
  2. Normal exclusion criteria for MRI; e.g., implanted metal, severe claustrophobia;
  3. Pre-existing dementia
  4. Pregnancy, as a precaution to prevent exposing them to multiple MRI scans in a 12-month period
  5. People in existing dependent or unequal relationships with any member of the research team, to protect against coercion

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): NCT02205424


Locations
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Australia, Victoria
Eastern Health
Box Hill, Victoria, Australia, 3128
Austin Health
Heidelberg, Victoria, Australia, 3084
Melbourne Health
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
The Florey Institute of Neuroscience and Mental Health
National Health and Medical Research Council, Australia
Investigators
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Principal Investigator: Amy G Brodtmann, MBBS PhD The Florey Institute of Neuroscience and Mental Health
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Keywords provided by Amy Brodtmann, The Florey Institute of Neuroscience and Mental Health:
Ischaemic stroke
Alzheimer's disease
Brain volume
Cortical thickness
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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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