Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery (the INSPIRE Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 912
- 试验地点
- 8
- 主要终点
- the 7-day incidence of new-onset silent brain infarction (SBI)
研究概览
简要总结
the purpose of the study is to investigate whether a combined anesthetic targets bundle, known as the NeuroFirst strategy, focused on neurological protection, can reduce the incidence of silent brain infarction (SBI) and perioperative neurocognitive disorders (PND) in patients undergoing cardiac surgery. Additionally, the trial will assess the safety of this strategy.
The NeuroFirst target bundle incorporates multiple parameters, including mean arterial pressure (MAP), bispectral index (BIS), regional cerebral oxygen saturation (rSO2), and arterial inflow temperature during cardiopulmonary bypass.
The primary question this study seeks to answer is: Does the NeuroFirst strategy reduce the incidence of SBI and PND in cardiac surgery?
To address this, researchers will compare the NeuroFirst strategy with routine institutional practices based on published guidelines. Participants will be randomly assigned to either the NeuroFirst group or the routine care group. All participants will undergo magnetic resonance imaging (MRI), be assessed using the Confusion Assessment Method (CAM) and the Montreal Cognitive Assessment (MoCA), and be followed for up to one year postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult patients aged 60 years or older
- •Receiving elective cardiovascular surgery with cardiopulmonary bypass
- •Written Informed consent provided
排除标准
- •Contraindication to MRI scanning
- •Not suitable for receiving interventions to achieve NeuroFirst target bundle
- •Unable to receive neuro-cognitive evaluation due to language, vision, or hearing impairments
- •Breastfeeding or pregnancy
- •Terminal illness with a life expectancy of less than 3 months
- •Mental or legal disability
- •current enrollment in other interventional study
结局指标
主要结局
the 7-day incidence of new-onset silent brain infarction (SBI)
时间窗: within 7 days postoperatively
New-onset silent brain infarction refers to newly developed cerebral infarctions detected on MRI, compared with the preoperative MRI, in the absence of any corresponding clinical symptoms of cerebral infarction.
次要结局
- Key Secondary Outcome: the 30-day incidence of perioperative neurocognitive disorders (PND)(within 30 days postoperatively)
- the 5-day incidence of postoperative delirium(within five days postoperatively)
- the 30-day incidence of new-onset overt stroke(within 30 days postoperatively)
- the 1-year incidence of new-onset overt stroke(within 1 year postoperatively)
- the 30-day composite incidence of major adverse events(within 30 days postoperatively)
- the 1-year composite incidence of major adverse events(within 1 year postoperatively)
- the 1-year incidence of perioperative neurocognitive disorders (PND)(within 1 year postoperatively)
- Key Secondary Outcome: the 30-day incidence of perioperative neurocognitive disorders (PND)(within 30 days postoperatively)
- the 5-day incidence of postoperative delirium(within five days postoperatively)
- the 30-day incidence of new-onset overt stroke(within 30 days postoperatively)
- the 1-year incidence of new-onset overt stroke(within 1 year postoperatively)
- the 30-day composite incidence of major adverse events(within 30 days postoperatively)
- the 1-year composite incidence of major adverse events(within 1 year postoperatively)
- the 30-day incidence of transient ischemic attack (TIA)(within 30 days postoperatively)
- the 1-year incidence of transient ischemic attack (TIA)(within 1 year postoperatively)
研究者
SHI Jia
Vice Chair, Department of Anesthesiology
Chinese Academy of Medical Sciences, Fuwai Hospital