Clinical trial NCT01980511: Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN
Official title: Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covert Postoperative Stroke
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
name: Health and Medical Research Fund
name: Prince of Wales Hospital, Shatin, Hong Kong
name: Chinese University of Hong Kong
First posted: 2013-11-11
Enrollment: 1116
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative cognitive dysfunction
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of acute postoperative covert stroke
timeFrame: 30 days
measure: Clinical 30-day outcomes (rated yes/no)
timeFrame: 30 days
measure: Clinical 1-year outcomes (rated yes/no)
timeFrame: 1 year
measure: Postoperative delirium
timeFrame: 30 days
measure: Physical function after surgery as assessed using the Modified Rankin Scale
timeFrame: 30 days and 1 year
measure: Physical function after surgery as assessed using the Lawton Instrumental Activities of Daily Living (iADL) Scale
timeFrame: 30 days and 1 year
measure: Quality of life after surgery
timeFrame: 30 days and 1 year
measure: Depressive symptoms after surgery
timeFrame: 30 days and 1 year
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: University Hospital, London Health Sciences
state: Ontario
city: Providencia
country: Chile
facility: Clinica Santa Maria
state: Santiago
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: SAR
city: Bangalore
country: India
facility: Narayana Health
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Lima
country: Peru
facility: Hospital Cayetano Heredia
city: Krakow
country: Poland
facility: Szpital Specjalistycznym
Study officials:
affiliation: Population Health Research Institute
name: P.J. Devereaux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Western Ontario, Canada
name: Marko Mrkobrada, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.