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Multicenter Study
. 2018 Jul 6;8(7):e021521.
doi: 10.1136/bmjopen-2018-021521.

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

Marko Mrkobrada  1 , Matthew T V Chan  2 , David Cowan  3 , Jessica Spence  3 , Douglas Campbell  4 , Chew Yin Wang  5 , David Torres  6 , German Malaga  7 , Robert D Sanders  8 , Carl Brown  9 , Alben Sigamani  10 , Wojciech Szczeklik  11 , Adam Andrew Dmytriw  12 , Ronit Agid  12 , Eric E Smith  13 , Michael D Hill  13 , Manas Sharma  1 , Mukul Sharma  3 , Scott Tsai  14 , Arun Mensinkai  14 , Demetrios J Sahlas  3 , Gordon Guyatt  3 , Shirley Pettit  15 , Ingrid Copland  15 , William K K Wu  2 , Simon C H Yu  2 , Tony Gin  2 , Pui San Loh  5 , Norlisah Ramli  5 , Yee Lein Siow  5 , Timothy G Short  4 , Ellen Waymouth  4 , Jonathan Kumar  4 , Monidipa Dasgupta  1 , John M Murkin  1 , Maite Fuentes  6 , Victor Ortiz-Soriano  7 , Heidi Lindroth  8 , Sara Simpson  9 , Daniel Sessler  16 , P J Devereaux  3
Affiliations
Multicenter Study

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

Marko Mrkobrada et al. BMJ Open. .

Abstract

Objectives: Covert stroke after non-cardiac surgery may have substantial impact on duration and quality of life. In non-surgical patients, covert stroke is more common than overt stroke and is associated with an increased risk of cognitive decline and dementia. Little is known about covert stroke after non-cardiac surgery.NeuroVISION is a multicentre, international, prospective cohort study that will characterise the association between perioperative acute covert stroke and postoperative cognitive function.

Setting and participants: We are recruiting study participants from 12 tertiary care hospitals in 10 countries on 5 continents.

Participants: We are enrolling patients ≥65 years of age, requiring hospital admission after non-cardiac surgery, who have an anticipated length of hospital stay of at least 2 days after elective non-cardiac surgery that occurs under general or neuraxial anaesthesia.

Primary and secondary outcome measures: Patients are recruited before elective non-cardiac surgery, and their cognitive function is measured using the Montreal Cognitive Assessment (MoCA) instrument. After surgery, a brain MRI study is performed between postoperative days 2 and 9 to determine the presence of acute brain infarction. One year after surgery, the MoCA is used to assess postoperative cognitive function. Physicians and patients are blinded to the MRI study results until after the last patient follow-up visit to reduce outcome ascertainment bias.We will undertake a multivariable logistic regression analysis in which the dependent variable is the change in cognitive function 1 year after surgery, and the independent variables are acute perioperative covert stroke as well as other clinical variables that are associated with cognitive dysfunction.

Conclusions: The NeuroVISION study will characterise the epidemiology of covert stroke and its clinical consequences. This will be the largest and the most comprehensive study of perioperative stroke after non-cardiac surgery.

Trial registration number: NCT01980511; Pre-results.

Keywords: adult anaesthesia; adult surgery; stroke medicine.

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Conflict of interest statement

Competing interests: EES reports grants from McMaster University, during the conduct of the study. TG reports grants from Food and Health Bureau, HK government, during the conduct of the study. PJD reports grants from Abbott Diagnostics, grants from Boehringer-Ingelheim, grants from Covidien, grants from Octopharma, grants from Phillips Healthcare, grants from Roche Diagnostics, grants from Stryker, outside the submitted work. DoC reports grants from Neurological Foundation of New Zealand, during the conduct of the study. MDH reports personal fees from Merck, non-financial support from Hoffmann-La Roche Canada, grants from Covidien (Medtronic), grants from Boehringer-Ingleheim, grants from Stryke, grants from Medtronic, outside the submitted work. In addition, MDH has a patent Systems and Methods for Assisting in Decision-Making and Triaging for Acute Stroke Patients pending to US Patent office Number: 62/086,077 and owns stock in Calgary Scientific, a company that focuses on medical imaging software, is a director of the Canadian Federation of Neurological Sciences, a not-for-profit group and has received grant support from Alberta Innovates Health Solutions, CIHR, Heart and Stroke Foundation of Canada, National Institutes of Neurological Disorders and Stroke. MTVC reports grants from Health and Medical Research Fund (11120321), Food and Health Bureau, Hong Kong government during the conduct of the study. TGS reports grants from New Zealand Neurological Foundation during the conduct of the study.

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