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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
  1. Marko Mrkobrada1,
  2. Matthew T V Chan2,
  3. David Cowan3,
  4. Jessica Spence3,
  5. Douglas Campbell4,
  6. Chew Yin Wang5,
  7. David Torres6,
  8. German Malaga7,
  9. Robert D Sanders8,
  10. Carl Brown9,
  11. Alben Sigamani10,
  12. Wojciech Szczeklik11,
  13. Adam Andrew Dmytriw12,
  14. Ronit Agid12,
  15. Eric E Smith13,
  16. Michael D Hill13,
  17. Manas Sharma1,
  18. Mukul Sharma3,
  19. Scott Tsai14,
  20. Arun Mensinkai14,
  21. Demetrios J Sahlas3,
  22. Gordon Guyatt3,
  23. Shirley Pettit15,
  24. Ingrid Copland15,
  25. William K K Wu2,
  26. Simon C H Yu2,
  27. Tony Gin2,
  28. Pui San Loh5,
  29. Norlisah Ramli5,
  30. Yee Lein Siow5,
  31. Timothy G Short4,
  32. Ellen Waymouth4,
  33. Jonathan Kumar4,
  34. Monidipa Dasgupta1,
  35. John M Murkin1,
  36. Maite Fuentes6,
  37. Victor Ortiz-Soriano7,
  38. Heidi Lindroth8,
  39. Sara Simpson9,
  40. Daniel Sessler16,
  41. P J Devereaux3
  1. 1 University of Western Ontario, London, Ontario, Canada
  2. 2 Chinese University of Hong Kong, Hong Kong, China
  3. 3 McMaster University, Hamilton, Ontario, Canada
  4. 4 Auckland City Hospital, Auckland, New Zealand
  5. 5 University Malaya, Kuala Lumpur, Malaysia
  6. 6 Clinica Santa Maria, Universidad de Los Andes, Santiago, Chile
  7. 7 Universidad Peruana Cayetano Heredia, Lima, Peru
  8. 8 University of Wisconsin, Madison, Wisconsin, USA
  9. 9 University of British Columbia, Vancouver, British Columbia, Canada
  10. 10 Narayana Health, Bangalore, Karnataka, India
  11. 11 Jagiellonian University Medical College, Krakow, Poland
  12. 12 University of Toronto, Toronto, Ontario, Canada
  13. 13 University of Calgary, Calgary, Alberta, Canada
  14. 14 Hamilton Health Sciences, Hamilton, Ontario, Canada
  15. 15 Population Health Research Institute, Hamilton, Ontario, Canada
  16. 16 Cleveland Clinic, Cleveland, Ohio, USA
  1. Correspondence to Dr Marko Mrkobrada; mmrkobr{at}uwo.ca

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.

  • stroke medicine
  • adult surgery
  • adult anaesthesia

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors MM, MTVC, DaC, JS, DoC, CYW, DT, GM, RDS, CB, AS, WS, RA, AAD, EES, MDH, MaS, MuS, ST, AM, DJS, GG, SP, IC, WKKW, SCHY, TG, PSL, NR, YLS, TGS, EW, JK, MD, JMM, MF, VO-S, HL, SS, DS and PJD contributed to the design of the study, involved in drafting of the manuscript and approved the final version for publication. MM had full access to all study data and took responsibility for data integrity and the accuracy of the data analysis.

  • Funding This work was supported by CIHR’s Strategy for Patient-Oriented Research, through the Ontario SPOR Support Unit, as well as the Ontario Ministry of Health and Long-Term Care; Health and Medical Research Fund (11120321), Food and Health Bureau, Hong Kong Government; Auckland District Health Board Charitable Trust; Neurological Foundation of New Zealand.

  • Disclaimer The views expressed are not necessarily shared with the Province of Ontario and the Ministry of Health and Long-Term Care. The study funders have no role in design and conduct of the study, collection, management, analysis, and interpretation of the data and preparation.

  • 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.

  • Patient consent Obtained.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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