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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 : Completed
First Posted : November 11, 2013
Last Update Posted : January 10, 2019
Sponsor:
Collaborators:
Hamilton Health Sciences Corporation
Health and Medical Research Fund
Prince of Wales Hospital, Shatin, Hong Kong
Chinese University of Hong Kong
Information provided by (Responsible Party):
McMaster University

Study Description
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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 Design
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Study Type : Observational
Actual Enrollment : 1116 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN
Actual Study Start Date : March 24, 2014
Actual Primary Completion Date : October 11, 2018
Actual Study Completion Date : November 6, 2018
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Postoperative cognitive dysfunction [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Incidence of acute postoperative covert stroke [ Time Frame: 30 days ]
    We will detect acute postoperative covert stroke using an MR study of the brain that will be performed between postoperative days 2 and 9.

  2. Clinical 30-day outcomes (rated yes/no) [ Time Frame: 30 days ]
    Overt stroke, transient ischemic attack, death, myocardial infarction, myocardial injury after noncardiac surgery, nonfatal cardiac arrest, major adverse cardiovascular events, cardiac revascularization procedures, bleeding, new atrial fibrillation, hypotension, congestive heart failure, new acute renal failure, infection and sepsis

  3. Clinical 1-year outcomes (rated yes/no) [ Time Frame: 1 year ]
    Overt stroke, transient ischemic attack, death, myocardial infarction, nonfatal cardiac arrest, major adverse cardiovascular events (composite), congestive heart failure, new acute renal failure, dementia and mild cognitive impairment

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

  5. Physical function after surgery as assessed using the Modified Rankin Scale [ Time Frame: 30 days and 1 year ]
    Physical function will be measured using the Modified Rankin Scale. The Modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people. The scale runs from 0-6, running from perfect health without symptoms to death. A higher score is worse.

  6. Physical function after surgery as assessed using the Lawton Instrumental Activities of Daily Living (iADL) Scale [ Time Frame: 30 days and 1 year ]
    Physical function will be measured using the Lawton Instrumental Activities of Daily Living (iADL) Scale. The Lawton Instrumental Activities of Daily Living Scale refers to people's daily self-care activities. It consists of 8 activities. A lower score is worse.

  7. 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. EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The first part contains the EQ-5D descriptive system, comprising of 5 questions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A higher score is worse. The second part is a vertical, visual analogue scale with the end-points of "best imaginable health state" and "worst imaginable health state". Scale runs from 0 to 100. A lower score is worse.

  8. 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 measure depressive symptoms. The 5-question version of the Geriatric Depression Scale scoring will be from 0 to 5. The higher values indicate increasing depressive symptoms.


Eligibility Criteria
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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 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.
Contacts and Locations
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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
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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
Prince of Wales Hospital, Shatin, Hong Kong
Chinese University of Hong Kong
Investigators
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Principal Investigator: P.J. Devereaux, MD, PhD Population Health Research Institute
Principal Investigator: Marko Mrkobrada, MD, FRCPC University of Western Ontario, Canada
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01980511    
Other Study ID Numbers: NeuroVISION v4.0
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019