Covert Postoperative StrokeNeuroVISIONNCT01980511
Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN
An observational study of Covert Postoperative Stroke, run by McMaster University at 11 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Covert Postoperative Stroke
- How many people
- 1,116 participants
- Where
- 11 sitesin 9 countries
- Study dates
- 24 Mar 2014to 6 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients undergoing elective non-cardiac surgery, ≥ 65 years old and an anticipated hospital stay of at least 2 days after elective noncardiac surgery that occurs under general or neuraxial anesthesia.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
11 sites in 9 countries.
11 sites in 9 countries
Canada3 sites
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
University Hospital, London Health Sciences
London, Ontario, N6A 5A5
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
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.
Read the detailed description
At the University of Wisconsin a planned sub study of NeuroVISION is being conducted aiming to enroll 100 patients with additional cognitive testing, MRI sequences and a preoperative MRI scan.
At Hamilton Juravinski Hospital, Hamilton General Hospital, Auckland City Hospital and Prince of Wales Hospital a planned sub study of NeuroVISION (PAFS - Perioperative Atrial Fibrillation and Postoperative Stroke) is being conducted aiming to enroll 400 participants. The purpose of this sub-study is to determine the prevalence of AF(Atrial Fibrillation) before surgery (i.e. "background" AF), as well of the incidence of AF after surgery using the Icentia CardioSTAT "patch-like" single lead heart rhythm monitor.
- Conditions
- Covert Postoperative Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative cognitive dysfunction
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.
Measured: 1 year
Secondary outcomes (8)
Incidence of acute postoperative covert stroke
We will detect acute postoperative covert stroke using an MR study of the brain that will be performed between postoperative days 2 and 9.
Measured: 30 days
Clinical 30-day outcomes (rated yes/no)
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
Measured: 30 days
Clinical 1-year outcomes (rated yes/no)
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
Measured: 1 year
Postoperative delirium
Delirium will be measured using the Cognitive Assessment Method (CAM).
Measured: 30 days
Physical function after surgery as assessed using the Modified Rankin Scale
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.
Measured: 30 days and 1 year
Physical function after surgery as assessed using the Lawton Instrumental Activities of Daily Living (iADL) Scale
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.
Measured: 30 days and 1 year
Quality of life after surgery
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.
Measured: 30 days and 1 year
Depressive symptoms after surgery
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.
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study start24 Mar 2014
- Primary completion11 Oct 2018
- Study completion6 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Covert Postoperative StrokeStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,116 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Health and Medical Research Fund, Prince of Wales Hospital, Shatin, Hong Kong, Chinese University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- P.J. Devereaux, MD, PhD, Principal investigator, Population Health Research InstituteMarko Mrkobrada, MD, FRCPC, Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980511
- Sponsor's protocol ID
- NeuroVISION v4.0
- Acronym
- NeuroVISION
- Status last verified
- Jan 2019
- First submitted
- 19 Sep 2013
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lv J, Taylor J, Curtis S, Kramer K, Kunkel D, Thakur S, Nair V, Banks MI, Pearce RA, Prabhakaran V, Lennertz R, Sanders RD. One-Year Brain Structural Changes Are Associated with Postoperative Delirium and Delayed Resolution of Interleukin-6. medRxiv [Preprint]. 2026 Jun 17:2026.05.03.26352074. doi: 10.64898/2026.05.03.26352074.
PubMed 42145626Taylor NL, Wehrman J, Banks MI, Nair V, Pearce RA, Kunkel D, Shine JM, Prabhakaran V, Lennertz R, Sanders RD. Dysfunctional resting state network connectivity predicts postoperative delirium after major surgery. Br J Anaesth. 2026 May;136(5):1509-1517. doi: 10.1016/j.bja.2025.11.036. Epub 2025 Dec 31.
PubMed 41475933Taylor J, Wu JG, Kunkel D, Parker M, Rivera C, Casey C, Naismith S, Teixeira-Pinto A, Maze M, Pearce RA, Lennertz R, Sanders RD. Resolution of elevated interleukin-6 after surgery is associated with return of normal cognitive function. Br J Anaesth. 2023 Oct;131(4):694-704. doi: 10.1016/j.bja.2023.05.023. Epub 2023 Jun 27.
PubMed 37385855Payne T, Taylor J, Casey C, Kunkel D, Parker M, Blennow K, Zetterberg H, Pearce RA, Lennertz RC, Sanders RD. Prospective analysis of plasma amyloid beta and postoperative delirium in the Interventions for Postoperative Delirium: Biomarker-3 study. Br J Anaesth. 2023 May;130(5):546-556. doi: 10.1016/j.bja.2023.01.020. Epub 2023 Feb 25.
PubMed 36842841Taylor J, Payne T, Casey C, Kunkel D, Parker M, Rivera C, Zetterberg H, Blennow K, Pearce RA, Lennertz RC, McCulloch T, Gaskell A, Sanders RD. Sevoflurane dose and postoperative delirium: a prospective cohort analysis. Br J Anaesth. 2023 Feb;130(2):e289-e297. doi: 10.1016/j.bja.2022.08.022. Epub 2022 Oct 1.
PubMed 36192219Taylor J, Parker M, Casey CP, Tanabe S, Kunkel D, Rivera C, Zetterberg H, Blennow K, Pearce RA, Lennertz RC, Sanders RD. Postoperative delirium and changes in the blood-brain barrier, neuroinflammation, and cerebrospinal fluid lactate: a prospective cohort study. Br J Anaesth. 2022 Aug;129(2):219-230. doi: 10.1016/j.bja.2022.01.005. Epub 2022 Feb 8.
PubMed 35144802Mrkobrada M, Chan MTV, Cowan D, Spence J, Campbell D, Wang CY, Torres D, Malaga G, Sanders RD, Brown C, Sigamani A, Szczeklik W, Dmytriw AA, Agid R, Smith EE, Hill MD, Sharma M, Sharma M, Tsai S, Mensinkai A, Sahlas DJ, Guyatt G, Pettit S, Copland I, Wu WKK, Yu SCH, Gin T, Loh PS, Ramli N, Siow YL, Short TG, Waymouth E, Kumar J, Dasgupta M, Murkin JM, Fuentes M, Ortiz-Soriano V, Lindroth H, Simpson S, Sessler D, Devereaux PJ. Rationale and design for the detection and neurological impact of cerebrovascular events in non-cardiac surgery patients cohort evaluation (NeuroVISION) study: a prospective international cohort study. BMJ Open. 2018 Jul 6;8(7):e021521. doi: 10.1136/bmjopen-2018-021521.
PubMed 29982215
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN
- ClinicalTrials.gov ID
- NCT01980511
- Acronym / sponsor ID
- NeuroVISION / NeuroVISION v4.0
- Conditions
- Covert Postoperative Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,116 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Health and Medical Research Fund, Prince of Wales Hospital, Shatin, Hong Kong, Chinese University of Hong Kong
- Study start
- 24 Mar 2014 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At the University of Wisconsin a planned sub study of NeuroVISION is being conducted aiming to enroll 100 patients with additional cognitive testing, MRI sequences and a preoperative MRI scan.
At Hamilton Juravinski Hospital, Hamilton General Hospital, Auckland City Hospital and Prince of Wales Hospital a planned sub study of NeuroVISION (PAFS - Perioperative Atrial Fibrillation and Postoperative Stroke) is being conducted aiming to enroll 400 participants. The purpose of this sub-study is to determine the prevalence of AF(Atrial Fibrillation) before surgery (i.e. "background" AF), as well of the incidence of AF after surgery using the Icentia CardioSTAT "patch-like" single lead heart rhythm monitor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients undergoing elective non-cardiac surgery, ≥ 65 years old and an anticipated hospital stay of at least 2 days after elective noncardiac surgery that occurs under general or neuraxial anesthesia.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative cognitive dysfunction
Time frame: 1 year
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.
8 secondary outcomes
Incidence of acute postoperative covert stroke
Time frame: 30 days
Clinical 30-day outcomes (rated yes/no)
Time frame: 30 days
Clinical 1-year outcomes (rated yes/no)
Time frame: 1 year
Postoperative delirium
Time frame: 30 days
Physical function after surgery as assessed using the Modified Rankin Scale
Time frame: 30 days and 1 year
Physical function after surgery as assessed using the Lawton Instrumental Activities of Daily Living (iADL) Scale
Time frame: 30 days and 1 year
Quality of life after surgery
Time frame: 30 days and 1 year
Depressive symptoms after surgery
Time frame: 30 days and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Derived from this study: PubMed 42145626Lv J, Taylor J, Curtis S, Kramer K, Kunkel D, Thakur S, Nair V, Banks MI, Pearce RA, Prabhakaran V, Lennertz R, Sanders RD. One-Year Brain Structural Changes Are Associated with Postoperative Delirium and Delayed Resolution of Interleukin-6. medRxiv [Preprint]. 2026 Jun 17:2026.05.03.26352074. doi: 10.64898/2026.05.03.26352074.
- Derived from this study: PubMed 41475933Taylor NL, Wehrman J, Banks MI, Nair V, Pearce RA, Kunkel D, Shine JM, Prabhakaran V, Lennertz R, Sanders RD. Dysfunctional resting state network connectivity predicts postoperative delirium after major surgery. Br J Anaesth. 2026 May;136(5):1509-1517. doi: 10.1016/j.bja.2025.11.036. Epub 2025 Dec 31.
- Derived from this study: PubMed 37385855Taylor J, Wu JG, Kunkel D, Parker M, Rivera C, Casey C, Naismith S, Teixeira-Pinto A, Maze M, Pearce RA, Lennertz R, Sanders RD. Resolution of elevated interleukin-6 after surgery is associated with return of normal cognitive function. Br J Anaesth. 2023 Oct;131(4):694-704. doi: 10.1016/j.bja.2023.05.023. Epub 2023 Jun 27.
- Derived from this study: PubMed 36842841Payne T, Taylor J, Casey C, Kunkel D, Parker M, Blennow K, Zetterberg H, Pearce RA, Lennertz RC, Sanders RD. Prospective analysis of plasma amyloid beta and postoperative delirium in the Interventions for Postoperative Delirium: Biomarker-3 study. Br J Anaesth. 2023 May;130(5):546-556. doi: 10.1016/j.bja.2023.01.020. Epub 2023 Feb 25.
- Derived from this study: PubMed 36192219Taylor J, Payne T, Casey C, Kunkel D, Parker M, Rivera C, Zetterberg H, Blennow K, Pearce RA, Lennertz RC, McCulloch T, Gaskell A, Sanders RD. Sevoflurane dose and postoperative delirium: a prospective cohort analysis. Br J Anaesth. 2023 Feb;130(2):e289-e297. doi: 10.1016/j.bja.2022.08.022. Epub 2022 Oct 1.
- Derived from this study: PubMed 35144802Taylor J, Parker M, Casey CP, Tanabe S, Kunkel D, Rivera C, Zetterberg H, Blennow K, Pearce RA, Lennertz RC, Sanders RD. Postoperative delirium and changes in the blood-brain barrier, neuroinflammation, and cerebrospinal fluid lactate: a prospective cohort study. Br J Anaesth. 2022 Aug;129(2):219-230. doi: 10.1016/j.bja.2022.01.005. Epub 2022 Feb 8.
- Derived from this study: PubMed 29982215Mrkobrada M, Chan MTV, Cowan D, Spence J, Campbell D, Wang CY, Torres D, Malaga G, Sanders RD, Brown C, Sigamani A, Szczeklik W, Dmytriw AA, Agid R, Smith EE, Hill MD, Sharma M, Sharma M, Tsai S, Mensinkai A, Sahlas DJ, Guyatt G, Pettit S, Copland I, Wu WKK, Yu SCH, Gin T, Loh PS, Ramli N, Siow YL, Short TG, Waymouth E, Kumar J, Dasgupta M, Murkin JM, Fuentes M, Ortiz-Soriano V, Lindroth H, Simpson S, Sessler D, Devereaux PJ. Rationale and design for the detection and neurological impact of cerebrovascular events in non-cardiac surgery patients cohort evaluation (NeuroVISION) study: a prospective international cohort study. BMJ Open. 2018 Jul 6;8(7):e021521. doi: 10.1136/bmjopen-2018-021521.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P.J. Devereaux, MD, PhD principal investigator
Population Health Research Institute
Marko Mrkobrada, MD, FRCPC principal investigator
University of Western Ontario, Canada
11 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covert Postoperative Stroke, run by McMaster University at 11 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada, United States, Chile, Hong Kong, India and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative cognitive dysfunction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01980511, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.