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

Covert Postoperative Stroke Clinical Trial

— NeuroVISION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980511
• Other study ID #: NeuroVISION v4.0
• Status: Completed
• Start date: March 24, 2014
• Est. completion date: November 6, 2018

Study information

• Verified date: January 2019
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1116
• Est. completion date: November 6, 2018
• Est. primary completion date: October 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covert Postoperative Stroke

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	University Hospital, London Health Sciences	London	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Chile	Clinica Santa Maria	Providencia	Santiago
Hong Kong	Prince of Wales Hospital	Shatin	SAR
India	Narayana Health	Bangalore
Malaysia	University Malaya Medical Centre	Kuala Lumpur
New Zealand	Auckland City Hospital	Auckland
Peru	Hospital Cayetano Heredia	Lima
Poland	Szpital Specjalistycznym	Krakow
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (5)

Lead Sponsor	Collaborator
McMaster University	Chinese University of Hong Kong, Hamilton Health Sciences Corporation, Health and Medical Research Fund, Food and Health Bureau, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative cognitive dysfunction	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.	1 year
Secondary	Incidence of acute postoperative covert stroke	We will detect acute postoperative covert stroke using an MR study of the brain that will be performed between postoperative days 2 and 9.	30 days
Secondary	Clinical 30-day outcomes (rated yes/no)	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	30 days
Secondary	Clinical 1-year outcomes (rated yes/no)	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	1 year
Secondary	Postoperative delirium	Delirium will be measured using the Cognitive Assessment Method (CAM).	30 days
Secondary	Physical function after surgery as assessed using the Modified Rankin Scale	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.	30 days and 1 year
Secondary	Physical function after surgery as assessed using the Lawton Instrumental Activities of Daily Living (iADL) Scale	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.	30 days and 1 year
Secondary	Quality of life after surgery	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.	30 days and 1 year
Secondary	Depressive symptoms after surgery	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.	30 days and 1 year