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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN
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Secondary ID [1]
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NeuroVISION v4.0
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Universal Trial Number (UTN)
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Trial acronym
NeuroVISION
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Covert Postoperative Stroke
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Postoperative cognitive dysfunction
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Assessment method [1]
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Our primary objective is to characterize the impact of postoperative covert stroke on neurocognitive function 1 year after elective noncardiac surgery, as measured by a decrease of two or more points on the Montreal Cognitive Assessment (MoCA) scale from preoperative baseline test to the 1-year follow-up.
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Timepoint [1]
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1 year
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Secondary outcome [1]
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Incidence of acute postoperative covert stroke
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Assessment method [1]
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We will detect acute postoperative covert stroke using an MR study of the brain that will be performed between postoperative days 2 and 9.
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Timepoint [1]
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30 days
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Secondary outcome [2]
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Clinical 30-day outcomes (rated yes/no)
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Assessment method [2]
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Overt stroke, transient ischemic attack, death, myocardial infarction, myocardial injury after noncardiac surgery, nonfatal cardiac arrest, major adverse cardiovascular events, cardiac revascularization procedures, bleeding, new atrial fibrillation, hypotension, congestive heart failure, new acute renal failure, infection and sepsis
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Timepoint [2]
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30 days
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Secondary outcome [3]
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Clinical 1-year outcomes (rated yes/no)
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Assessment method [3]
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Overt stroke, transient ischemic attack, death, myocardial infarction, nonfatal cardiac arrest, major adverse cardiovascular events (composite), congestive heart failure, new acute renal failure, dementia and mild cognitive impairment
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Timepoint [3]
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1 year
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Secondary outcome [4]
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Postoperative delirium
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Assessment method [4]
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Delirium will be measured using the Cognitive Assessment Method (CAM).
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Timepoint [4]
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30 days
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Secondary outcome [5]
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Physical function after surgery as assessed using the Modified Rankin Scale
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Assessment method [5]
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Physical function will be measured using the Modified Rankin Scale. The Modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people. The scale runs from 0-6, running from perfect health without symptoms to death. A higher score is worse.
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Timepoint [5]
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30 days and 1 year
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Secondary outcome [6]
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Physical function after surgery as assessed using the Lawton Instrumental Activities of Daily Living (iADL) Scale
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Assessment method [6]
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Physical function will be measured using the Lawton Instrumental Activities of Daily Living (iADL) Scale. The Lawton Instrumental Activities of Daily Living Scale refers to people's daily self-care activities. It consists of 8 activities. A lower score is worse.
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Timepoint [6]
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30 days and 1 year
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Secondary outcome [7]
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Quality of life after surgery
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Assessment method [7]
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We will use the EQ-5D questionnaire to assess the patients' health-related quality of life. EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The first part contains the EQ-5D descriptive system, comprising of 5 questions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A higher score is worse. The second part is a vertical, visual analogue scale with the end-points of "best imaginable health state" and "worst imaginable health state". Scale runs from 0 to 100. A lower score is worse.
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Timepoint [7]
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30 days and 1 year
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Secondary outcome [8]
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Depressive symptoms after surgery
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Assessment method [8]
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We will use the 5-question version of the Geriatric Depression Scale (GDS-5) to measure depressive symptoms. The 5-question version of the Geriatric Depression Scale scoring will be from 0 to 5. The higher values indicate increasing depressive symptoms.
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Timepoint [8]
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30 days and 1 year
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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
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/03/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/11/2018
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Sample size
Target
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Accrual to date
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Final
1116
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Wisconsin
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Country [2]
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Canada
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State/province [2]
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British Columbia
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Country [3]
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Canada
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State/province [3]
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Ontario
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Country [4]
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Chile
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State/province [4]
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Santiago
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Country [5]
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Hong Kong
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State/province [5]
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SAR
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Country [6]
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India
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State/province [6]
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Bangalore
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Country [7]
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Malaysia
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State/province [7]
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Kuala Lumpur
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Country [8]
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New Zealand
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State/province [8]
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Auckland
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Country [9]
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Peru
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State/province [9]
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Lima
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Country [10]
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Poland
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State/province [10]
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Krakow
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Funding & Sponsors
Primary sponsor type
Other
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Name
McMaster University
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Hamilton Health Sciences Corporation
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Health and Medical Research Fund
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Prince of Wales Hospital, Shatin, Hong Kong
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Chinese University of Hong Kong
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
The NeuroVISION Study will characterize the incidence, impact, and risk factors of covert
stroke in adults undergoing noncardiac surgery. We will determine the incidence of acute
covert stroke using an MRI study of the brain in the days following noncardiac surgery. We
will characterize the epidemiology and the impact of covert stroke in patients undergoing
noncardiac surgery, and its association with cerebral deoxygenation.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01980511
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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P.J. Devereaux, MD, PhD
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Address
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Population Health Research Institute
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01980511
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