The goal of this clinical trial is to learn if an AI-based imaging software, Methinks Stroke Suite, can reduce the time to transfer stroke patients who need thrombectomy from local stroke centers to specialized centers. The study focuses on acute stroke patients who are initially evaluated at local stroke centers that cannot perform endovascular therapy (EVT). The main questions it aims to answer are:
* Does Methinks Stroke Suite reduce the time it takes to decide if a patient needs to be transferred for thrombectomy? * How accurate is the AI software in identifying patients who are candidates for EVT?
Researchers will compare the AI-based workflow to a historical cohort to see if the Methinks Stroke Suite improves transfer decisions and treatment times.
Participants will:
* Undergo a CT scan at the local stroke center, which will be analyzed by Methinks Stroke Suite. * Be transferred to a thrombectomy-capable center if the AI + clinical judgment identifies them as potential EVT candidates. * Be followed for 90 days after their stroke to assess recovery outcomes.
Suspected acute stroke patients
>18 years with no upper age limit
Included < 24 h since last seen well
Non-contrast CT is available at the local stroke center
Patients in a coma (NIHSS item of consciousness >1)
Patients with unstable clinical status who require emergent life support care
Subject imaging does not meet Image Acquisition and DICOM Tag Requirements
Subjects with an acute stroke evaluated in a local stroke center. Sample size is projected to be 250 patients.
Cohort
Prospective
Methinks software
DeviceIntroduction in the stroke code workflow the Methinks AI software capable of detecting LVO on NCCT and CTA, and ICH on NCCT.
Normal CT scans evaluation
Other interventionThe control group is obtained from a historical cohort at each participating center. We include consecutive suspected acute stroke patients who meet the same inclusion/exclusion criteria defined above, except for Methinks image processing.
Reduction of the time from patient arrival to the transfer decision to a thrombectomy-capable center
The primary goal is to assess how much the Methinks Stroke Suite reduces the time from patient arrival at the Local-SC to the transfer decision (time-to-transfer decision) to a thrombectomy-capable center.
Performance evaluation of the NCCT-LVO algorithm for detecting large vessel occlusions (LVO)
Assessment of Methinks Stroke SuiteI stroke accuracy at predicting the presence of vessel occlusions.
Global reduction of workflow times
Reduction of Door-in to Door-out at the Local-SC, arrival at the Local-SC to groin puncture for patients receiving EVT
Improvement in treatment rates
Populational EVT thrombectomy rates
Functional outcome at 90 days
mRS at 90 days
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Hospital Universitari Vall d'Hebron Research Institute
Lead sponsor
Methinks Software SL
Collaborator
