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

N/ACompletedNCT01980511

McMaster University1,116 enrolled

Overview

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.

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

Enrollment

1,116

Conditions

Covert Postoperative Stroke

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (11)

University of Wisconsin

Madison, Wisconsin, United States

St. Paul's Hospital

Vancouver, British Columbia, Canada

Hamilton Health Sciences

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 30 days

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

Time frame: 30 days

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

Time frame: 1 year

Postoperative delirium

Delirium will be measured using the Cognitive Assessment Method (CAM).

Time frame: 30 days

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.

Data from ClinicalTrials.gov

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