Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01980511




Registration number
NCT01980511
Ethics application status
Date submitted
19/09/2013
Date registered
11/11/2013
Date last updated
10/01/2019

Titles & IDs
Public title
Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN
Scientific title
Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN
Secondary ID [1] 0 0
NeuroVISION v4.0
Universal Trial Number (UTN)
Trial acronym
NeuroVISION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covert Postoperative Stroke 0 0
Condition category
Condition code

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

Outcomes
Primary outcome [1] 0 0
Postoperative cognitive dysfunction
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Incidence of acute postoperative covert stroke
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Clinical 30-day outcomes (rated yes/no)
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Clinical 1-year outcomes (rated yes/no)
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Postoperative delirium
Timepoint [4] 0 0
30 days
Secondary outcome [5] 0 0
Physical function after surgery as assessed using the Modified Rankin Scale
Timepoint [5] 0 0
30 days and 1 year
Secondary outcome [6] 0 0
Physical function after surgery as assessed using the Lawton Instrumental Activities of Daily Living (iADL) Scale
Timepoint [6] 0 0
30 days and 1 year
Secondary outcome [7] 0 0
Quality of life after surgery
Timepoint [7] 0 0
30 days and 1 year
Secondary outcome [8] 0 0
Depressive symptoms after surgery
Timepoint [8] 0 0
30 days and 1 year

Eligibility
Key inclusion criteria
* Age =65 years old
* An anticipated hospital stay of at least 2 days after elective noncardiac surgery that occurs under general or neuraxial anesthesia
* Written informed consent for potential participation prior to noncardiac surgery
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Contraindication to MRI (e.g. implanted devices not safe for MRI studies, claustrophobia)
* Unable or unwilling to attend the follow-up appointments
* Documented history of dementia
* Residing in a nursing home
* Undergoing carotid artery surgery or intracranial surgery
* Unable to complete neurocognitive testing due to language, vision or hearing impairment
* Unable to communicate with the research staff due to language barriers
* Patients who do not undergo their research MRI study after surgery
* Patients who do not complete a baseline MoCA questionnaire
* Patients who suffer an acute overt clinical stroke after the index surgery, but before their research MR study
* Previously enrolled in the NeuroVISION Study.

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
24/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/11/2018
Sample size
Target
Accrual to date
Final
1116
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Wisconsin
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Chile
State/province [4] 0 0
Santiago
Country [5] 0 0
Hong Kong
State/province [5] 0 0
SAR
Country [6] 0 0
India
State/province [6] 0 0
Bangalore
Country [7] 0 0
Malaysia
State/province [7] 0 0
Kuala Lumpur
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
Peru
State/province [9] 0 0
Lima
Country [10] 0 0
Poland
State/province [10] 0 0
Krakow

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Hamilton Health Sciences Corporation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Health and Medical Research Fund
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Prince of Wales Hospital, Shatin, Hong Kong
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Chinese University of Hong Kong
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
P.J. Devereaux, MD, PhD
Address 0 0
Population Health Research Institute
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

No information has been provided regarding IPD availability


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/NCT01980511