Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000970448
Ethics application status
Approved
Date submitted
20/02/2013
Date registered
25/07/2016
Date last updated
24/02/2020
Date data sharing statement initially provided
30/01/2019
Date results provided
30/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is stroke neurodegenerative? A longitudinal study of changes in brain volume and cognition following stroke (CANVAS: Cognition And Neocortical Volume After Stroke)
Scientific title
Is stroke neurodegenerative? A longitudinal study of changes in brain volume and cognition following stroke (CANVAS: Cognition And Neocortical Volume After Stroke)
Secondary ID [1] 281988 0
CANVAS Study
Universal Trial Number (UTN)
Trial acronym
CANVAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic stroke
 288418 0
Alzheimer's disease 288420 0
Condition category
Condition code
Stroke 288770 288770 0 0
Ischaemic
Neurological 289315 289315 0 0
Alzheimer's disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
135 ishaemic stroke patients will have an 3 Tesla Magnetic Resonance Imaging (MRI) scan, and undergo cognitive testing, at five time points - baseline; 3 months post-stroke; 1 year post-stroke; 3 years post-stroke; and 5 years post-stroke.. Cognitive tests include the MOCA, HVLT-R, REY Copy, Trails A and B, Cogstate battery, BNT, Token Test, NART, Digit Span, and Digit Symbol tasks.

For each MRI scan, participants will lie down flat, and still, in the scanner, for between 30 minutes (first scan) and 55 minutes (each review scan).
Intervention code [1] 286558 0
Not applicable
Comparator / control treatment
Results for ischaemic stroke patients will be compared against 40 healthy controls, who are matched on sex, age, and vascular risk factors (e.g., smoking, diabetes, cholesterol, hypertension).
Control group
Active

Outcomes
Primary outcome [1] 288906 0
Our primary imaging outcome is brain volume change at 3 months versus 3 years, as measured by 3T MRI. We expect that stroke patients will exhibit greater and more rapid loss of whole brain and hippocampal volume, over time, than controls.

Timepoint [1] 288906 0
3 years post-stroke.
Primary outcome [2] 288907 0
Our primary cognitive outcome is a dementia diagnosis, in a proportion of stroke patients, at 3 years. Cognitive test scores will be reviewed, and participants who are thought to have a dementia will be referred on to appropriate members of Austin Health, who are not part of the research team, for formal neuropsychological assessment.

We expect that loss of brain volume will be associated with subsequent cognitive decline.
Timepoint [2] 288907 0
3 years post-stroke.
Secondary outcome [1] 301322 0
Hippocampal volume at 3 months, as measured by structural magnetic resonance imaging, will be predictive of a dementia diagnosis at 3 years post-stroke. A dementia diagnosis will be made by members of Austin Health, who are not part of the research team.
Timepoint [1] 301322 0
3 years post-stroke.

Eligibility
Key inclusion criteria
Inclusion criteria for the stroke group include:

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

Inclusion criteria for healthy controls are the same, excluding, of course, the stroke diagnosis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for stroke patients and control participants are the same. These include:

1. Significant medical comorbidities precluding participation in cognitive testing, or making survival for 3 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 research team, to protect against coercion.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
18/04/2011
Date of last participant enrolment
Anticipated
Actual
1/07/2015
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
175
Accrual to date
Final
175
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 630 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 631 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 632 0
Box Hill Hospital - Box Hill

Funding & Sponsors
Funding source category [1] 286767 0
Government body
Name [1] 286767 0
National Health and Medical Research Council (NHMRC)
Country [1] 286767 0
Australia
Funding source category [2] 291363 0
Charities/Societies/Foundations
Name [2] 291363 0
The Myer Foundation and Sidney Myer Fund
Country [2] 291363 0
Australia
Funding source category [3] 291364 0
Charities/Societies/Foundations
Name [3] 291364 0
J.O. and J.R. Wicking Trust
Country [3] 291364 0
Australia
Funding source category [4] 291365 0
Charities/Societies/Foundations
Name [4] 291365 0
The Collie Trusts
Country [4] 291365 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road, Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 285547 0
Charities/Societies/Foundations
Name [1] 285547 0
The Florey Institute of Neuroscience and Mental Health
Address [1] 285547 0
Melbourne Brain Centre, 245 Burgundy St, Heidelberg 3084
Country [1] 285547 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288832 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 288832 0
Ethics committee country [1] 288832 0
Australia
Date submitted for ethics approval [1] 288832 0
Approval date [1] 288832 0
10/03/2011
Ethics approval number [1] 288832 0
H2012/04650
Ethics committee name [2] 288833 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [2] 288833 0
Ethics committee country [2] 288833 0
Australia
Date submitted for ethics approval [2] 288833 0
Approval date [2] 288833 0
02/11/2012
Ethics approval number [2] 288833 0
2012.164
Ethics committee name [3] 289164 0
Eastern Health Human Research Ethics Committee
Ethics committee address [3] 289164 0
Ethics committee country [3] 289164 0
Australia
Date submitted for ethics approval [3] 289164 0
Approval date [3] 289164 0
18/03/2013
Ethics approval number [3] 289164 0
E22/1213

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37986 0
Prof Amy Brodtmann
Address 37986 0
Melbourne Brain Centre
245 Burgundy Street,
Heidelberg, VIC 3084
Country 37986 0
Australia
Phone 37986 0
+61 3 9035 7004
Fax 37986 0
+61 3 9035 7304
Email 37986 0
agbrod@unimelb.edu.au
Contact person for public queries
Name 37987 0
Laura Bird
Address 37987 0
Melbourne Brain Centre
245 Burgundy Street,
Heidelberg, VIC 3084
Country 37987 0
Australia
Phone 37987 0
+61 3 9035 7086
Fax 37987 0
+61 3 9035 7304
Email 37987 0
laura.bird@florey.edu.au
Contact person for scientific queries
Name 37988 0
Amy Brodtmann
Address 37988 0
Melbourne Brain Centre
245 Burgundy Street,
Heidelberg, VIC 3084
Country 37988 0
Australia
Phone 37988 0
+61 3 9035 7004
Fax 37988 0
+61 3 9035 7304
Email 37988 0
agbrod@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Any demographic, medical, cognitive and MRI data collected at the 5-year review session for stroke participants and healthy controls will be uploaded to an online database.
When will data be available (start and end dates)?
Data collection for the 5-year time-point will be complete in December 2020. We anticipate that 5-year data will be made available 12 months after we have published the main findings relating to this data point. We have not set an end date at this stage.
Available to whom?
The data will only be made available to researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Researchers can perform any analyses that achieve the aims in the approved proposal.
How or where can data be obtained?
Data will be uploaded to an online database. Researchers whose proposals have been approved by the CANVAS study committee will be provided with a web address and login details.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.