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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02205424




Registration number
NCT02205424
Ethics application status
Date submitted
20/03/2014
Date registered
31/07/2014

Titles & IDs
Public title
Cognition And Neocortical Volume After Stroke
Scientific title
Is Stroke Neurodegenerative? A Longitudinal Study of Brain Volume and Cognitive Decline Following Stroke (CANVAS: Cognition And Neocortical Volume After Stroke).
Secondary ID [1] 0 0
APP-1020526
Universal Trial Number (UTN)
Trial acronym
CANVAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic Stroke 0 0
Alzheimer's Disease 0 0
Vascular Dementia 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in total brain volume between 3 month and 3 year time-points
Timepoint [1] 0 0
Between 3 months and 3 years post-stroke
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Between 3 months and 3 years post-stroke
Secondary outcome [2] 0 0
Difference in hippocampal volume between 3 month and 3 year time-points in stroke and control participants.
Timepoint [2] 0 0
Between 3 months and 3 years post-stroke
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Between 3 months and 3 years post-stroke

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2021
Sample size
Target
Accrual to date
Final
175
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Eastern Health - Box Hill
Recruitment hospital [2] 0 0
Austin Health - Heidelberg
Recruitment hospital [3] 0 0
Melbourne Health - Parkville
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
The Florey Institute of Neuroscience and Mental Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Amy G Brodtmann, MBBS PhD
Address 0 0
The Florey Institute of Neuroscience and Mental Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02205424