Automatic PredICtion of Edema After Stroke

• Conditions: Stroke, Acute; Brain Edema

• Registration Number: NCT04057690
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

To use machine learning for early detection of malignant brain edema in patients with MCA ischemia

Detailed Description

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.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-08-13
• Study First Posted: 2019-08-15
• Status Verified: 2020-11
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-03
• Primary Completion: 2021-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• 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

Exclusion Criteria

• Non-acute MCA infarct
• < subtotal MCA infarct

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with stroke-related malignant edema after recanalization treatment detected by deep learning algorithms	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.

Secondary Outcome Measures

Name	Time	Method
Number of correctly identified specific imaging findings for early detection of malignant edema	4/2019-3/2022	Used specific imaging findings for early detection of malignant brain edema are Collateral status, Clot Burden Score, Vein Score, Change in CSF volume. In this study the specific image findings are manually annotated and also automatically detected using deep learning algorithms. Secondary outcome measures are Sensitivity/Specificity/NPV/PPV of specific imaging findings identified by deep learning algorithms.

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany