NCT01980511

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,116

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
9 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

March 24, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2018

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

4.6 years

First QC Date

September 19, 2013

Last Update Submit

January 9, 2019

Conditions

Covert Postoperative Stroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Incidence of acute postoperative covert stroke

    30 days

  • Clinical 30-day outcomes (rated yes/no)

    30 days

  • Clinical 1-year outcomes (rated yes/no)

    1 year

  • Postoperative delirium

    30 days

  • Physical function after surgery as assessed using the Modified Rankin Scale

    30 days and 1 year

  • +3 more secondary outcomes

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

University Hospital, London Health Sciences

London, Ontario, N6A 5A5, Canada

Location

Clinica Santa Maria

Providencia, Santiago Metropolitan, 7520378, Chile

Location

Prince of Wales Hospital

Shatin, SAR, Hong Kong

Location

Narayana Health

Bangalore, India

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Hospital Cayetano Heredia

Lima, Lima31, Peru

Location

Szpital Specjalistycznym

Krakow, Poland

Location

Related Publications (6)

  • Taylor 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. 2025 Dec 30:S0007-0912(25)00844-X. doi: 10.1016/j.bja.2025.11.036. Online ahead of print.

    PMID: 41475933DERIVED

  • Taylor 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.

    PMID: 37385855DERIVED

  • Payne 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.

    PMID: 36842841DERIVED

  • 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.

    PMID: 36192219DERIVED

  • 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.

    PMID: 35144802DERIVED

  • 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.

    PMID: 29982215DERIVED

Study Officials

  • P.J. Devereaux, MD, PhD

    Population Health Research Institute

    PRINCIPAL INVESTIGATOR

  • Marko Mrkobrada, MD, FRCPC

    University of Western Ontario, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2013

First Posted

November 11, 2013

Study Start

March 24, 2014

Primary Completion

October 11, 2018

Study Completion

November 6, 2018

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

IN(1)HK(1)CL(1)PE(1)US(1)PL(1)CA(3)MY(1)NZ(1)