Actively Recruiting
Segmentation and Modeling for Accurate Reconstruction of CT Angiography of Intracranial Large Vessel Occlusion with Artificial Intelligence: a Stepped-wedge, Cluster-randomized Controlled Trial
Led by Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Updated on 2024-10-16
174
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Acute ischemic stroke caused by a blockage in a large blood vessel inside the brain is a serious condition that often leads to disability and death. This trial investigates whether using an artificial intelligence (AI) algorithm to improve the visualization of these blockages on CT angiography scans can help doctors perform endovascular thrombectomy treatments more quickly and accurately. The study is designed as a stepped-wedge cluster-randomized trial to evaluate the impact of integrating AI into stroke care workflows. Participants will receive one of two approaches: standard care without AI-assisted imaging or care with the AI algorithm providing automated reconstruction and segmentation of CT angiography scans to highlight the occluded vessel segments. Physicians will decide treatment based on clinical evaluation and images, with the AI images available during the intervention period. All patients deemed eligible will receive standard endovascular thrombectomy treatment per current guidelines. Throughout the study, researchers will measure the time to first pass of the clot during thrombectomy and other outcomes immediately after the procedure, such as flow restoration success, hemorrhage rates, and complications. Functional independence and mortality will be assessed up to 90 days post-treatment. The study aims to improve patient outcomes by using AI to assist doctors in navigating blocked vessels more effectively during stroke treatment.
CONDITIONS
Brief Title
AI-Driven CTA Reconstruction for Intracranial LVO
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female, 18 years of age or older.
- Patients who present with signs and/or symptoms concerning acute ischemic stroke.
- Patients who undergo noncontrast CT and CT angiography imaging.
- Patients determined to have an intracranial large vessel occlusion (including the internal carotid artery, middle cerebral artery M1 segment, and M2 segment), and eligible for endovascular treatment.
You will not qualify if you...
- CT imaging with severe motion artifacts.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to the time of endovascular treatment
Participants undergo CT angiography imaging with or without AI-activated image reconstruction as part of their stroke evaluation and treatment planning. Diagnosis and treatment decisions are made by treating physicians based on clinical evaluation and imaging review following routine standard of care.
1 visit (in-person)
Duration - 90 days post-treatment
Participants are monitored for safety and outcomes including procedural complications, functional independence, and mortality after endovascular treatment.
Visits immediately after treatment, at 24 hours, and up to 90 days post-treatment
Trial Site Locations
Total: 2 locations
1
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200233
Active, Not Recruiting
2
Shanghai Sixth People's Hospital
Shanghai, China, 200023
Actively Recruiting
Research Team
Y
Yueqi Zhu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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