Automatic Prediction of Malignant Brain Edema After Middle Cerebral Artery Ischemic -Stroke
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 1,687
- 试验地点
- 19
- 主要终点
- Number of patients with stroke-related malignant edema after recanalization treatment detected by deep learning algorithms
研究概览
简要总结
To use machine learning for early detection of malignant brain edema in patients with MCA ischemia
详细描述
Malignant cerebral edema following large ischemic strokes account for up to 10% of all ischemic strokes. Mortality rates are high and most of the survivors are left severely disabled. Although decompressive craniectomy has been shown to significantly decrease mortality, high morbidity rates among survivors are reported. The optimal timepoint when neurosurgical decompression should be performed in the individual patient varies and is a subject of debate.
Early prediction of malignant brain edema to identify those patients who benefit from surgical treatment is a clinical challenge. The aim of this study is to use machine learning for comprehensive analysis of CT images as well as clinical data from 1500 patients with large ischemic MCA strokes in oder to develop a model for early prediction of malignant brain edema. In a first step algorithms automatically identify characteristic imaging features and clinical data of 1400 retrospective data sets to create a multistage model (learning phase). This is followed by a validation phase where the model is tested with 100 other retrospective data sets.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ≥ subtotal MCA infarct (M1-M2 occlusion)
- •with or without malignant brain swelling
- •with or without reperfusion therapy
- •with or without neurosurgical decompression
- •with or without death following malignant brain edema
排除标准
- •Non-acute MCA infarct
- •< subtotal MCA infarct
结局指标
主要结局
Number of patients with stroke-related malignant edema after recanalization treatment detected by deep learning algorithms
时间窗: 4/2019-3/2022
Deep learning algorithms will be used for automatic identification of specific image findings and specific clinical data that indicate a stroke-related malignant edema. Primary outcome measures are Sensitivity/Specificity/negative predictive value/positive predictive value of early detection of patients developing stroke-related malignant edema based on initial CT and 24 hour follow up CT and clinical parameters.
次要结局
- Number of correctly identified specific imaging findings for early detection of malignant edema(4/2019-3/2022)
