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

NCT ID: NCT01980511

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-24

Study Completion Date

2018-11-06

Brief Summary

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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

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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.

Conditions

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Covert Postoperative Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role collaborator

Health and Medical Research Fund

OTHER_GOV

Sponsor Role collaborator

Prince of Wales Hospital, Shatin, Hong Kong

OTHER

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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P.J. Devereaux, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Marko Mrkobrada, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Western Ontario, Canada

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

University Hospital, London Health Sciences

London, Ontario, Canada

Site Status

Clinica Santa Maria

Providencia, Santiago Metropolitan, Chile

Site Status

Prince of Wales Hospital

Shatin, SAR, Hong Kong

Site Status

Narayana Health

Bangalore, , India

Site Status

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

Hospital Cayetano Heredia

Lima, , Peru

Site Status

Szpital Specjalistycznym

Krakow, , Poland

Site Status

Countries

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United States Canada Chile Hong Kong India Malaysia New Zealand Peru Poland

References

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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.

Reference Type DERIVED
PMID: 37385855 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36842841 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36192219 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35144802 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29982215 (View on PubMed)

Other Identifiers

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NeuroVISION v4.0

Identifier Type: -

Identifier Source: org_study_id

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