Differentiating Between Brain Hemorrhage and Contrast

NCT06032819 | Unknown

• 1 other identifier: SYSKY-2023-865-01
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ischemic Stroke

Keywords

Hemorrhage; Contrast Media Extravasation; Artificial Intelligence; Mechanical Revascularisation

Outcome Measures

Primary Outcomes (1)

• Develop a deep learning model to differentiate brain hemorrhage from contrast agent extravasation, and evaluate the model performance and generalization ability

  The accuracy, sensitivity, specificity, precision, and recall of the model will be calculated, and confusion matrix will be display.

  2024-12

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From December 2017 to June 2023, patients with acute ischemic stroke or intracranial arterial stenosis who underwent mechanical vascularization at 10 centers will be retrospectively enrolled.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Hong Kong University of Science and Technology: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• The Seventh Affiliated Hospital of Sun Yat-sen University: collaborator
• Peking University Shenzhen Hospital: collaborator
• The Third Affiliated Hospital of Guangzhou Medical University: collaborator
• The Third Affiliated Hospital of Southern Medical University: collaborator
• Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University: collaborator
• Shantou Central Hospital: collaborator
• Dongguan People's Hospital: collaborator
• The First People's Hospital of Qinzhou: collaborator
• Guangdong 999 Brain Hospital: collaborator

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhage; Extravasation of Diagnostic and Therapeutic Materials

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Central Study Contacts

Meiwei Chen

CONTACT

+86 18898534109; chenmw7@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 13, 2023
• Study Start: September 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09