Differentiating Between Brain Hemorrhage and Contrast

Artificial Intelligence for Differentiating Between Brain Hemorrhage and Contrast Extravasation After Mechanical Revascularization in Acute Ischemic Stroke

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Stroke

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Meiwei Chen; Phone Number: +86 18898534109; Email: chenmw7@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Hemorrhage; Contrast Media Extravasation; Mechanical Revascularisation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Hemorrhage; Intracranial Hemorrhages
• Other Study ID Numbers: SYSKY-2023-865-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No