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

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ClinicalTrials.gov Identifier: NCT01980511
Recruitment Status : Active, not recruiting
First Posted : November 11, 2013
Last Update Posted : April 24, 2018
Sponsor:
Collaborators:
Hamilton Health Sciences Corporation
Health and Medical Research Fund, Food and Health Bureau, Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Chinese University of Hong Kong
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease
Covert Postoperative Stroke

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.


Study Type : Observational
Actual Enrollment : 1121 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN
Study Start Date : March 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018



Primary Outcome Measures :
  1. Postoperative cognitive dysfunction [ Time Frame: 1 year ]
    Cognitive dysfunction, as measured by a decrease of on the Montreal Cognitive Assessment (MoCA) scale.


Secondary Outcome Measures :
  1. Measuring the incidence of acute postoperative covert stroke [ Time Frame: 30 days ]
    We will detect postoperative covert strokes using a MRI study of the brain that will be performed between postoperative days 3 and 9.

  2. Measuring postoperative delirium [ Time Frame: 30 days ]
    Delirium will be measured using the Cognitive Assessment Method (CAM).

  3. Measuring physical function after surgery [ Time Frame: 30 days and 1 year ]
    Physical function will be measured using two instruments; the Modified Rankin Scale and the Lawton Instrumental Activities of Daily Living (iADL) Scale.

  4. Measuring quality of life after surgery [ Time Frame: 30 days and 1 year ]
    We will use the EQ-5D questionnaire to assess the patients' health-related quality of life.

  5. Measuring depressive symptoms after surgery [ Time Frame: 30 days and 1 year ]
    We will use the 5-question version of the Geriatric Depression Scale (GDS-5) to depressive symptoms.

  6. Measuring clinical outcomes [ Time Frame: 30 days and 1 year ]
    Clinical outcomes: acute cerebral ischemia, covert stroke, overt stroke, transient ischemic attack, delirium, death, myocardial infarction (MI), myocardial injury after noncardiac surgery (MINS), nonfatal cardiac arrest, major adverse cardiovascular events (composite), cardiac revascularization procedures, bleeding, new atrial fibrillation, hypotension, congestive heart failure, new acute renal failure, infection, and dementia and mild cognitive impairment.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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 to lie flat or still),
  • 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,
  • Previously enrolled in the NeuroVISION Study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980511


Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53706
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
University Hospital, London Health Sciences
London, Ontario, Canada, N6A 5A5
Chile
Clinica Santa Maria
Providencia, Santiago, Chile, 7520378
Hong Kong
Prince of Wales Hospital
Shatin, SAR, Hong Kong
India
Narayana Health
Bangalore, India
Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1023
Peru
Hospital Cayetano Heredia
Lima, Peru, Lima31
Poland
Szpital Specjalistycznym
Krakow, Poland
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Health and Medical Research Fund, Food and Health Bureau, Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Chinese University of Hong Kong
Investigators
Principal Investigator: P.J. Devereaux, MD, PhD Population Health Research Institute
Principal Investigator: Marko Mrkobrada, MD, FRCPC University of Western Ontario, Canada