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临床试验/NCT04057690
NCT04057690进行中(未招募)不适用

Automatic Prediction of Malignant Brain Edema After Middle Cerebral Artery Ischemic -Stroke

University Hospital Tuebingen19 个研究点 分布在 3 个国家目标入组 1,687 人开始时间: 2019年4月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (19)

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