NCT04057690

Brief Summary

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

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,687

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
3 countries

19 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

4.5 years

First QC Date

April 25, 2019

Last Update Submit

September 3, 2025

Conditions

Stroke, AcuteBrain Edema

Keywords

Malignant Brain EdemaStroke, AcutePrediction

Outcome Measures

Primary Outcomes (1)

  • Number of patients with stroke-related malignant edema after recanalization treatment detected by deep learning algorithms

    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.

    4/2019-3/2022

Secondary Outcomes (1)

  • Number of correctly identified specific imaging findings for early detection of malignant edema

    4/2019-3/2022

Study Arms (2)

MCA ischemia without malignant edema

MCA ischemia without malignant edema

MCA ischemia with malignant edema

MCA ischemia without malignant edema w/o surgical treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1500 retrospective datasets will be collected from 5 large German stroke units. Data sets include imaging data and clinical data from patients with subtotal MCA infarcts (M1-M2 occlusion), with or without malignant brain swelling, with or without reperfusion therapy, with or without neurosurgical decompression, and with or without death following malignant brain edema. Data sets from patients who have died following malignant brain edema will be included. Each data set consists of initial NCCT, CTA, (DSA if available), and follow-up NCCT until 14 days after stroke onset as well as clinical data.

You may qualify if:

  • 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

You may not qualify if:

  • Non-acute MCA infarct
  • \< subtotal MCA infarct

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

St. John's Hospital

Vienna, Austria

Location

Charité Universitätsmedizin Berlin

Berlin, Germany

Location

Universitätsklinikum Bonn

Bonn, Germany

Location

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

Bremen, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Klinikum der Medizinischen Hochschule Hannover

Hanover, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Klinikum der Ludwig-Maximilians-Universität München

Munich, Germany

Location

Technische Universität München

Munich, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Universitätsklinikum Regensburg

Regensburg, Germany

Location

Klinikum Stuttgart

Stuttgart, Germany

Location

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

Hertie Institute for AI in Brain Health

Tübingen, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Germany

Location

BRAINOMIX Limited

Oxford, United Kingdom

Location

MeSH Terms

Conditions

StrokeBrain Edema

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sven Poli, MD MSc

    sven.poli@uni-tuebingen.de

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2019

First Posted

August 15, 2019

Study Start

April 1, 2019

Primary Completion

September 30, 2023

Study Completion

December 31, 2025

Last Updated

September 10, 2025

Record last verified: 2025-09

Locations

GB(1)DE(17)AU(1)