Actively Recruiting
Accelerating Referral for Thrombectomy in Acute Stroke Patients Using an Artificial Intelligence-based Software
Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2024-12-18
250
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
H
Hospital Universitari Vall d'Hebron Research Institute
Lead Sponsor
M
Methinks Software SL
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Methinks Stroke Suite, an AI-based imaging software, to see if it can help speed up the transfer of acute stroke patients who may need thrombectomy from local stroke centers to specialized centers. The study focuses on patients initially assessed at centers that cannot perform endovascular therapy (EVT). The main goals are to find out whether the software reduces the time to decide on patient transfer and how accurately it identifies candidates for EVT. The study compares patient care after integrating Methinks Stroke Suite into the stroke workflow with a historical group treated before its use. Patients will have a CT scan analyzed by the AI software at the local center. If the software and clinical judgment suggest thrombectomy might be needed, patients are transferred to specialized centers. If no large vessel occlusion is detected, further imaging like CT angiography may be done to reassess. This is an open-label, quasi-experimental study conducted across multiple centers in Catalonia, Spain. Participants will undergo CT scans at their local stroke center, with imaging data processed by the Methinks software. They will be followed for 90 days after their stroke to assess recovery and functional outcomes. Researchers will measure time from arrival to transfer decision, evaluate the software's accuracy in detecting large vessel occlusions, monitor treatment rates, and gather clinician feedback on using the software. Safety during patient transfers will also be tracked. The study plans to enroll about 250 patients and includes a follow-up period of 3 months after stroke.
CONDITIONS
Brief Title
Accelerating Referral for Thrombectomy in Acute Stroke Patients Using an Artificial Intelligence-based Software
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected acute stroke patients
- Aged 18 years or older with no upper age limit
- Included less than 24 hours since last seen well
- Non-contrast CT scan available at the local stroke center
- Image processed by Methinks Stroke Suite
- Informed consent obtained from the patient or legally designated representative
You will not qualify if you...
- Patients in a coma (consciousness score greater than 1)
- Patients requiring emergent life support due to unstable clinical status
- Imaging that does not meet Image Acquisition and DICOM Tag requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 24 hours since last known well
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During initial hospital stay at local stroke center
Participants undergo evaluation with CT scans processed by the Methinks Stroke Suite AI software to assist stroke neurologists in decision-making for potential transfer to thrombectomy-capable centers.
1 visit (in-person)
Duration - 90 days
Participants are followed for 90 days post-stroke to assess functional recovery and safety outcomes.
Follow-up visits up to 90 days
Trial Site Locations
Total: 2 locations
1
Hospital General de Manresa Granollers
Granollers, Barcelona, Spain, 08402
Actively Recruiting
2
Hospital Vall Hebron
Barcelona, Spain
Actively Recruiting
Research Team
M
Marta Olivé
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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