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
|Condition or disease|
|Covert Postoperative Stroke|
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|
|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|
- Postoperative cognitive dysfunction [ Time Frame: 1 year ]Cognitive dysfunction, as measured by a decrease of on the Montreal Cognitive Assessment (MoCA) scale.
- 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 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.
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
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53706|
|Canada, British Columbia|
|St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8L 2X2|
|University Hospital, London Health Sciences|
|London, Ontario, Canada, N6A 5A5|
|Clinica Santa Maria|
|Providencia, Santiago, Chile, 7520378|
|Prince of Wales Hospital|
|Shatin, SAR, Hong Kong|
|University Malaya Medical Centre|
|Kuala Lumpur, Malaysia, 59100|
|Auckland City Hospital|
|Auckland, New Zealand, 1023|
|Hospital Cayetano Heredia|
|Lima, Peru, Lima31|
|Principal Investigator:||P.J. Devereaux, MD, PhD||Population Health Research Institute|
|Principal Investigator:||Marko Mrkobrada, MD, FRCPC||University of Western Ontario, Canada|