Automatic PredICtion of Edema After Stroke

NCT04057690 · tracked via the Priya Life Science Germany tracker

Sponsor

University Hospital Tuebingen

Phase

Observational

Started

2019-04-01

Last updated

2025-09-10

Condition(s) studied

Stroke, AcuteBrain Edema

Study summary

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

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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.

Trial sites (19)

Facility	City	Region
St. John's Hospital	Vienna	Austria
Charité Universitätsmedizin Berlin	Berlin	Germany
Universitätsklinikum Bonn	Bonn	Germany
Fraunhofer- Gesellschaft zur Förderung der angewandten Forschung e.V., Fraunhofer MEVIS	Bremen	Germany
Universitätsklinikum Düsseldorf	Düsseldorf	Germany
Universitätsklinikum Hamburg-Eppendorf	Hamburg	Germany
Klinikum der Medizinischen Hochschule Hannover	Hanover	Germany
Universitätsklinikum Heidelberg	Heidelberg	Germany
Universitätsklinikum Leipzig	Leipzig	Germany
Klinikum der Ludwig-Maximilians-Universität München	Munich	Germany
Technische Universität München	Munich	Germany
Universitätsklinikum Münster	Münster	Germany
Universitätsklinikum Regensburg	Regensburg	Germany
Klinikum Stuttgart	Stuttgart	Germany
University Hospital Tuebingen	Tübingen	Germany
Hertie Institute for AI in Brain Health	Tübingen	Germany
Universitätsklinikum Ulm	Ulm	Germany
Universitätsklinikum Würzburg	Würzburg	Germany
BRAINOMIX Limited	Oxford	United Kingdom

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04057690 on ClinicalTrials.gov ↗ ← All trials in Germany