Automatic PredICtion of Edema After Stroke

Last updated: April 30, 2021
Sponsor: University Hospital Tuebingen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT04057690
APICES
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Non-acute MCA infarct
  • < subtotal MCA infarct

Study Design

Total Participants: 1500
Study Start date:
April 01, 2019
Estimated Completion Date:
March 31, 2023

Study 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.

Connect with a study center

  • University Hospital Tuebingen

    Tuebingen, 72076
    Germany

    Active - Recruiting

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