Automatic PredICtion of Edema After Stroke

Last updated: September 3, 2025
Sponsor: University Hospital Tuebingen
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Stroke

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: 1687
Study Start date:
April 01, 2019
Estimated Completion Date:
December 31, 2025

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

  • St. John's Hospital

    Vienna 2761369,
    Austria

    Site Not Available

  • Charité Universitätsmedizin Berlin

    Berlin 2950159,
    Germany

    Site Not Available

  • Universitätsklinikum Bonn

    Bonn 2946447,
    Germany

    Site Not Available

  • Fraunhofer- Gesellschaft zur Förderung der angewandten Forschung e.V., Fraunhofer MEVIS

    Bremen 2944388,
    Germany

    Site Not Available

  • Universitätsklinikum Düsseldorf

    Düsseldorf 2934246,
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg 2911298,
    Germany

    Site Not Available

  • Klinikum der Medizinischen Hochschule Hannover

    Hanover 2910831,
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg 2907911,
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig

    Leipzig 2879139,
    Germany

    Site Not Available

  • Klinikum der Ludwig-Maximilians-Universität München

    Munich 2867714,
    Germany

    Site Not Available

  • Technische Universität München

    Munich 2867714,
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster 2867543,
    Germany

    Site Not Available

  • Universitätsklinikum Regensburg

    Regensburg 2849483,
    Germany

    Site Not Available

  • Klinikum Stuttgart

    Stuttgart 2825297,
    Germany

    Site Not Available

  • University Hospital Tuebingen

    Tuebingen, 72076
    Germany

    Site Not Available

  • Hertie Institute for AI in Brain Health

    Tübingen 2820860,
    Germany

    Site Not Available

  • University Hospital Tuebingen

    Tübingen 2820860, 72076
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm 2820256,
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg

    Würzburg 2805615,
    Germany

    Site Not Available

  • BRAINOMIX Limited

    Oxford 2640729,
    United Kingdom

    Site Not Available

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