Differentiating Between Brain Hemorrhage and Contrast

NCT ID: NCT06032819

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-30

Study Completion Date

2024-12-31

Brief Summary

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The goal of this observational study is to use artificial intelligence to differentiate cerebral hemorrhage from contrast agent extravasation after mechanical revascularization in ischemic stroke.

The main question it aims to answer is: Whether artificial intelligence can help differentiate brain hemorrhage from contrast agent extravasation.

Patients with intracranial high-density lesions on CT scans within 24h after mechanical revascularization will be included. Expected to enroll 500 patients. The type of high-density lesion is determined according to dual-energy CT images or follow-up images. Patients will be divided into training group, validation and testing groups by stratified random sampling (6:2:2). After the images and the image labels are obtained, deep learning artificial intelligence will be used to learn the image characteristics and establish a diagnostic model, and the model performance and generalization ability will be evaluated.

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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hemorrhage

The result of the Intracranial hyper-density on CT images is determined by dual-energy CT or follow-up images: hyper-density can be seen on the virtual non-contrasted image of dual-energy CT, or high density persist longer than 48 hours.

No interventions assigned to this group

simple contrast extravasation

There is no Intracranial hyper-density on the virtual non-contrast images of dual-energy CT, or the follow-up CT show that the hyper-density is absorbed within 48 hours.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

(1) patients underwent non-enhanced head CT after mechanical vascularization; (2) initial post-operative non-enhanced head CT was performed within 24 h after mechanical vascularization; and (3) intracranial hyper-intensity, which was defined as an objectively higher density than the surrounding grey or white matter in the parenchyma or higher density than cerebrospinal fluid in ventricles and cisterns, could be seen on the initial non-enhanced head CT after mechanical vascularization.

Exclusion Criteria

(1) the follow-up time of non-enhanced head CT after mechanical vascularization was less than 24 h; (2) artifacts (e.g. metal artifacts or motion artifacts) affected the hyper-intensity in CT images; and (3) patients underwent craniotomy after mechanical vascularization, which made it difficult to identify the area of hyper-intensity.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hong Kong University of Science and Technology

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

The Seventh Affiliated Hospital of Sun Yat-sen University

OTHER

Sponsor Role collaborator

Peking University Shenzhen Hospital

OTHER

Sponsor Role collaborator

The Third Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

The Third Affiliated Hospital of Southern Medical University

OTHER_GOV

Sponsor Role collaborator

Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University

UNKNOWN

Sponsor Role collaborator

Shantou Central Hospital

OTHER

Sponsor Role collaborator

Dongguan People's Hospital

OTHER_GOV

Sponsor Role collaborator

The First People's Hospital of Qinzhou

UNKNOWN

Sponsor Role collaborator

Guangdong 999 Brain Hospital

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Meiwei Chen

Role: CONTACT

+86 18898534109

Other Identifiers

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SYSKY-2023-865-01

Identifier Type: -

Identifier Source: org_study_id

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