Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT04057690

Automatic PredICtion of Edema After Stroke

Automatic Prediction of Malignant Brain Edema After Middle Cerebral Artery Ischemic -Stroke

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
1,687 (actual)
Sponsor
University Hospital Tuebingen · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2019-04-01
Primary completion
2023-09-30
Completion
2025-12-31
First posted
2019-08-15
Last updated
2025-09-10

Locations

19 sites across 3 countries: Austria, Germany, United Kingdom

Source: ClinicalTrials.gov record NCT04057690. Inclusion in this directory is not an endorsement.