ANZCTR - Registration

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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]

CANVAS Study

Universal Trial Number (UTN)

Trial acronym

CANVAS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Ischaemic stroke

Alzheimer's disease

Condition category

Condition code

Stroke

Ischaemic

Neurological

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]

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]

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]

3 years post-stroke.

Primary outcome [2]

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]

3 years post-stroke.

Secondary outcome [1]

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]

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]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [2]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [3]

Box Hill Hospital - Box Hill

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

Level 1 16 Markus Clarke Street, Canberra, ACT 2601

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

The Myer Foundation and Sidney Myer Fund

Address [2]

Little Lonsdale Street Melbourne Victoria 8011

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

J.O. and J.R. Wicking Trust

Address [3]

55 Collins Street, Melbourne, VIC 3000

Country [3]

Australia

Funding source category [4]

Charities/Societies/Foundations

Name [4]

The Collie Trusts

Address [4]

55 Collins Street, Melbourne, VIC 3000

Country [4]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

145 Studley Road, Heidelberg VIC 3084

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

The Florey Institute of Neuroscience and Mental Health

Address [1]

Melbourne Brain Centre, 245 Burgundy St, Heidelberg 3084

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

Office for Research
145 Studley Road,
Heidelberg, VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/03/2011

Ethics approval number [1]

H2012/04650

Ethics committee name [2]

Melbourne Health Human Research Ethics Committee

Ethics committee address [2]

Office for Research
6 East, Central Building
The Royal Melbourne Hospital
300 Grattan Street
PARKVILLE  VIC  3050

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

02/11/2012

Ethics approval number [2]

2012.164

Ethics committee name [3]

Eastern Health Human Research Ethics Committee

Ethics committee address [3]

5 Arnold Street, Box Hill 
Victoria 3128

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

18/03/2013

Ethics approval number [3]

E22/1213

Summary

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 we still know very little 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). 

We hypothesise 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.

Trial website

http://www.florey.edu.au/research/cognitive-neuroscience/is-stroke-degenerative-a-longitudinal-study-of-cognitive-and-changes-regional-brain-volume-following-stroke-

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Amy Brodtmann

Address

Melbourne Brain Centre 245 Burgundy Street, Heidelberg, VIC 3084

Country

Australia

Phone

+61 3 9035 7004

Fax

+61 3 9035 7304

[email protected]

Contact person for public queries

Name

Laura Bird

Address

Melbourne Brain Centre 245 Burgundy Street, Heidelberg, VIC 3084

Country

Australia

Phone

+61 3 9035 7086

Fax

+61 3 9035 7304

[email protected]

Contact person for scientific queries

Name

Amy Brodtmann

Address

Melbourne Brain Centre 245 Burgundy Street, Heidelberg, VIC 3084

Country

Australia

Phone

+61 3 9035 7004

Fax

+61 3 9035 7304

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• The data will only be made available to researchers who provide a methodologically sound proposal.

Conditions for requesting access:
• -

What individual participant data might 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.

What types of analyses could be done with individual participant data?

• Researchers can perform any analyses that achieve the aims in the approved proposal.

When can requests for individual participant data be made (start and end dates)?

From:
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.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• 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.

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically