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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

Tracking Information
First Submitted Date September 19, 2013
First Posted Date November 11, 2013
Last Update Posted Date January 10, 2019
Actual Study Start Date March 24, 2014
Actual Primary Completion Date October 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2019)
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.
Original Primary Outcome Measures
 (submitted: November 4, 2013)
Postoperative cognitive dysfunction [ Time Frame: 1 year ]
Cognitive dysfunction, as measured by a decrease of on the Montreal Cognitive Assessment (MoCA) scale.
Change History
Current Secondary Outcome Measures
 (submitted: January 9, 2019)
  • 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.
  • 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
  • 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
  • Postoperative delirium [ Time Frame: 30 days ]
    Delirium will be measured using the Cognitive Assessment Method (CAM).
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: November 4, 2013)
  • 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.
  • Measuring cerebral oxygenation [ Time Frame: 30 days ]
  • Measuring postoperative delirium [ Time Frame: 30 days ]
    Delirium will be measured using the Cognitive Assessment Method (CAM).
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN
Official Title Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Covert Postoperative Stroke
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 9, 2019)
1116
Original Estimated Enrollment
 (submitted: November 4, 2013)
600
Actual Study Completion Date November 6, 2018
Actual Primary Completion Date October 11, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   Chile,   Hong Kong,   India,   Malaysia,   New Zealand,   Peru,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01980511
Other Study ID Numbers NeuroVISION v4.0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party McMaster University
Study Sponsor McMaster University
Collaborators
  • Hamilton Health Sciences Corporation
  • Health and Medical Research Fund
  • 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
PRS Account McMaster University
Verification Date January 2019