The fMRI in CardiaC arrEst With Uncertain Prognosis (FACE-UP) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Cerebral Performance Category Score 1-2
研究概览
简要总结
The goal of this observational study is to determine whether specific advanced MRI measures are associated with functional outcomes in patients who are comatose after cardiac arrest. The main question[s] it aims to answer are:
Aim 1: Determine if stimulus-based functional MRI (fMRI)-measured activations are independently associated with favorable neurological outcomes after cardiac arrest
Aim 2: Determine if resting state functional MRI (rs-fMRI)-measured functional network connectivity is independently associated with favorable neurological outcomes after cardiac arrest.
Aim 3: Determine if diffusion tensor imaging (DTI)-measured white matter integrity is associated with favorable neurological outcomes after cardiac arrest.
Participants will undergo advanced MRI sequences at time of clinical MRI, and will be followed for 6 months post-arrest.
详细描述
Our goal here is to determine whether advanced functional MRI and DTI sequences add actionable prognostic information relative to standard clinical MRI in patients who remain comatose after cardiac arrest. We plan the following specific analyses:
Aim 1: We will use logistic regression to measure the association between our primary outcome and fMRI BOLD response to (a) passive language stimuli, (b) motor imagery or (c) passive sensory stimuli, in a model with age, Glasgow Coma Scale (GCS) score at time of MRI, and presence of anoxic injury on clinical diffusion weighted MRI.
Aim 2: We will use logistic regression to measure the association between our primary outcome and default mode network resting state functional connectivity, in a model with age, Glasgow Coma Scale (GCS) score at time of MRI, and presence of anoxic injury on clinical diffusion weighted MRI.
Aim 3: We will use logistic regression to measure the association between our primary outcome and diffusion tensor imaging (DTI)-measured mean white matter fractional anisotropy, in a model with age, Glasgow Coma Scale (GCS) score at time of MRI, and presence of anoxic injury on clinical diffusion weighted MRI.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •survive of an in or out of hospital cardiac arrest
排除标准
- •Drug overdose
- •Opinion of medical team patient unlikely to survive more than 24 hours (severe concurrent medical illness, dilated and unreactive pupils, etc..)
- •Following verbal commands (MD or RN note) once TTM is complete and normothermia is achieved (Day 2 or 3; Day of admission is Hospital Day 0). If no TTM is administered, this can be assessed on Hospital Day
- •Following verbal commands (study team assessment) at time of MRI
- •Family planning to WLST at time of enrollment
- •Non English speaker (okay if English not primary language, as long as they can understand it)
- •Permanent Contraindication to MRI (some kind of implanted metal)
结局指标
主要结局
Cerebral Performance Category Score 1-2
时间窗: 6 months
A standardized scale describing a patients overall level of independent function. Ranges from 1 (asymptomatic) to 5 (death). Levels 1-2 reflect patients who are functionally independent in their iADLs.
次要结局
- Cerebral Performance Category Score 1-3(2 weeks)
研究者
Samuel Snider, MD
Principal Investigator, Assistant Professor of Neurology at Brigham and Women's Hospital
Brigham and Women's Hospital