Cognition And Neocortical Volume After Stroke (CANVAS)

June 9, 2022 updated by: Amy Brodtmann, The Florey Institute of Neuroscience and Mental Health

Is Stroke Neurodegenerative? A Longitudinal Study of Brain Volume and Cognitive Decline Following Stroke (CANVAS: Cognition And Neocortical Volume After Stroke).

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Eastern Health
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Parkville, Victoria, Australia, 3050
        • Melbourne Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Between 3 months and 3 years post-stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Between 3 months and 3 years post-stroke
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.
Between 3 months and 3 years post-stroke
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.
Between 3 months and 3 years post-stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Florey Institute of Neuroscience and Mental Health

Collaborators

National Health and Medical Research Council, Australia

Investigators

  • Principal Investigator: Amy G Brodtmann, MBBS PhD, The Florey Institute of Neuroscience and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2011

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

March 20, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimate)

July 31, 2014

Study Record Updates

Last Update Posted (Actual)

June 10, 2022

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APP-1020526

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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