Prospective Identification of Hypoxic Ischemic Brain Injury Using Portable Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cortex- DGN HIBI score
研究概览
简要总结
The goal of this study is to look for brain injury in patients who had a cardiac arrest, using portable brain imaging. The portable nature of this test will also allow for serial imaging so the investigators can understand how brain injury changes over days. The results of this study may allow for bedside imaging to be available at centers without specialized imaging centers and may identify markers of brain injury that help to select the patients most likely to benefit for clinical trials.
详细描述
Cardiac arrest occurs when the heart stops beating. This can occur for many reasons ranging from a heart attack to a drug overdose. It claims close to 500,000 lives a year. Even though the heartbeat is restored, blood flow to the brain remains below what is required for normal function. Brain injury is common in patients who had a cardiac arrest and few return to independence. Most patients are in a coma following cardiac arrest. Some patients wake up within the first days to week, but most do not. Physicians rely on tests, such as brain imaging, brain wave tests, and lab tests to help predict recovery. Magnetic resonance imaging is a type of brain test used to look for injury to the brain. This type of imaging is not available in community centers and requires transport out of the intensive care unit. Transport can be dangerous in patients who are on life support. New tools have been developed that allow for imaging at the bedside.
These portable machines allow patients to stay connected to all necessary monitoring and decrease interruptions in treatment.
Primary Objective:
A. To evaluate inter-rater agreement of low-field portable MRI as compared to high-field conventional MRI for measuring hypoxic ischemic brain injury severity, using a qualitative MRI scoring system.
B. To acquire early low-field portable MRI (<6 and <24 hours from cardiac arrest) to establish the specificity and positive predictive value of early DWI lesions for predicting hypoxic ischemic brain injury on later conventional 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
- 否
入选标准
- •Unresponsive immediately after ROSC from IHCA or OHCA
- •Age ≥ 18 years of age
- •Conventional MRI is clinically indicated
- •Treatment with temperature control
排除标准
- •MRI contraindication according to the American Heart Association guidelines
- •Inability to tolerate supine positioning for 30 minutes
- •Diffuse loss of grey-white differentiation and sulcal effacement on head computed tomography within 6 hours of ROSC
研究组 & 干预措施
Cardiac arrest with Return of Spontaneous Circulation (ROSC)
All enrolled patients will have two to three portable MRIs ( <6 hours, 6-24 hours and one within 12 (+/- 12) hours of conventional MRI) and one conventional MRI. Standard of care will occur per the clinical team and this study will not interfere with standard of care.
干预措施: portable MRI scanner (Device)
结局指标
主要结局
Cortex- DGN HIBI score
时间窗: up to 6 hours post cardiac arrest, up to 24 hours post cardiac arrest and within 12 (+/- 12) hours of conventional MRI
Hypoxic ischemic brain injury will be assessed using the Cortex- DGN HIBI score on a scale of 0-40. Higher scores indicate greater injury.
次要结局
未报告次要终点