Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,116
- 试验地点
- 11
- 主要终点
- Postoperative cognitive dysfunction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Postoperative cognitive dysfunction
时间窗: 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.
次要结局
- Incidence of acute postoperative covert stroke(30 days)
- Clinical 30-day outcomes (rated yes/no)(30 days)
- Quality of life after surgery(30 days and 1 year)
- Clinical 1-year outcomes (rated yes/no)(1 year)
- Postoperative delirium(30 days)
- Physical function after surgery as assessed using the Modified Rankin Scale(30 days and 1 year)
- Physical function after surgery as assessed using the Lawton Instrumental Activities of Daily Living (iADL) Scale(30 days and 1 year)
- Depressive symptoms after surgery(30 days and 1 year)