Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN (NeuroVISION)

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.

Study Overview

• Status: Completed
• Conditions: Covert Postoperative Stroke

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 Type: Observational
• Enrollment (Actual): 1116

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton Health Sciences
    • London, Ontario, Canada, N6A 5A5
      • University Hospital, London Health Sciences
• Chile
  • Santiago
    • Providencia, Santiago, Chile, 7520378
      • Clinica Santa Maria
• Hong Kong
  • SAR
    • Shatin, SAR, Hong Kong
      • Prince of Wales Hospital
• India
  • Bangalore, India
    • Narayana Health
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
• Peru
  • Lima, Peru, Lima31
    • Hospital Cayetano Heredia
• Poland
  • Krakow, Poland
    • Szpital Specjalistycznym
• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	1 year
Postoperative delirium	Delirium will be measured using the Cognitive Assessment Method (CAM).	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.	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.	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.	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.	30 days and 1 year

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Chinese University of Hong Kong; Hamilton Health Sciences Corporation; Prince of Wales Hospital, Shatin, Hong Kong; Health and Medical Research Fund
• Investigators: Principal Investigator: Marko Mrkobrada, MD, FRCPC, University of Western Ontario, Canada

Publications and helpful links

General Publications

• Taylor 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.
• Taylor 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.
• Mrkobrada 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2014
• Primary Completion (Actual): October 11, 2018
• Study Completion (Actual): November 6, 2018

Study Registration Dates

• First Submitted: September 19, 2013
• First Submitted That Met QC Criteria: November 4, 2013
• First Posted (Estimate): November 11, 2013

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 9, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: NeuroVISION v4.0