Study Overview:
The CATalyze-AI study aims to evaluate the impact of integrating the Methinks Stroke
Suite, an artificial intelligence (AI) imaging software, into the workflow of stroke
centers unable to perform endovascular therapy (EVT). This is a prospective, multicenter,
quasi-experimental clinical trial focusing on acute stroke patients initially assessed at
local stroke centers (Local-SC) in Catalonia, Spain. The introduction of this AI
algorithm is expected to improve the decision-making process for transferring patients
who may benefit from EVT, reducing time-to-transfer decisions.
Primary Objective:
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.
Secondary Objectives:
Accuracy of Methinks: Evaluate the software's accuracy in identifying large vessel
occlusion (LVO) candidates requiring EVT.
Workflow Efficiency: Measure global workflow improvements, including door-in to door-out
(DIDO) times and time to groin puncture.
Thrombectomy Rates: Assess population-wide EVT rates. Functional Outcomes: Evaluate
patient recovery based on functional outcomes at 90 days post-stroke.
Safety Analysis: Monitor complications during patient transfers, especially in cases
where Methinks does not suspect LVO.
Clinician Experience: Conduct a parallel study to assess the satisfaction of clinicians
using the software.
Study Design:
This is a quasi-experimental, open-label trial. The Methinks Stroke Suite will be
integrated into the usual stroke care workflow of participating centers, and the results
will be compared with a historical cohort. Subjects will be followed for 90 days
post-stroke to evaluate outcomes.
Study Setting and Population:
The study will take place across several centers in Catalonia, Spain, including:
Hospital Universitari Vall d'Hebron Hospital General de Granollers Consorci Hospitalari
de Vic Hospital Clínic de Barcelona Centre Hospitalari Manresa - Fundació Althaia Mútua
de Terrassa The target population is acute stroke patients evaluated at Local-SC. A
sample size of 250 patients is projected. All patients meeting the inclusion criteria
will be enrolled, and consent for data collection will be obtained at the destination
center.
Eligibility Criteria:
Inclusion Criteria:
Suspected acute stroke. Patients aged 18 years or older, with no upper age limit. Stroke
onset <24 hours since last known well. A non-contrast CT (NCCT) performed at the
Local-SC and processed by the Methinks Stroke Suite.
Informed consent from the patient or legally designated representative.
Exclusion Criteria:
Patients in a coma (NIHSS > 1). Patients requiring life support due to unstable
clinical status. Imaging that does not meet DICOM Tag and Acquisition Requirements.
Historical Cohort:
For time-reduction comparisons, a control group will be selected retrospectively from
each participating center. These control patients will match study participants based on
age, pre-stroke functional status, baseline NIHSS score, working hours (office vs.
off-hours), and use of intravenous thrombolysis.
Intervention and Workflow:
When patients arrive at a Local-SC, they will be evaluated for suspected stroke and
undergo a CT scan. Methinks Stroke Suite will analyze the imaging in real-time, and its
results will be shared with the referring stroke neurologist. Based on the AI results and
clinical judgment, patients suspected of LVO will be transferred to a
thrombectomy-capable center.
In cases where Methinks does not detect LVO, CTA (CT Angiography) may be performed to
reassess the patient's status. Transfer decisions will be based on clinical judgment
and the results of this additional imaging.
Primary Outcome:
The primary outcome is the reduction in time-to-transfer decision, defined as the time
from patient arrival at the Local-SC to the notification to Emergency Medical Services
(EMS) for patient transfer to a thrombectomy-capable center.
Secondary Outcomes:
Accuracy of Methinks Stroke Suite in detecting LVOs. Improvement in workflow times,
including the time from Local-SC arrival to groin puncture.
Increased EVT rates among patients flagged by Methinks as LVO positive. Safety outcomes,
including complications during transfer. Functional outcomes based on the modified Rankin
Scale (mRS) at 90 days. Clinician satisfaction with the use of Methinks Stroke Suite.
Sample Size and Power Calculation:
The study aims to include 152 patients to detect a 10-minute reduction in transfer
decision time, with 80% power and a significance level of 0.05. To account for potential
enrollment failures, the target is set at 250 patients.
Blinding and Statistical Analysis:
The trial is not blinded, as the intervention is visible to clinicians. However,
neuroimaging and clinical data will be assessed by blinded reviewers to ensure unbiased
evaluation. Statistical analysis will compare time-to-transfer decision between groups
and measure accuracy (sensitivity, specificity) of Methinks predictions. Quantitative
variables will be described using means and standard deviations, while qualitative
variables will be analyzed using chi-square or Fisher's exact tests.
Data Management:
Data will be collected through existing stroke registries (CICAT, SITREM, TICAT, and
SONIIA). Methinks Stroke Suite will automatically log patient imaging data. Blinded
investigators will review the data to ensure it complies with the protocol.
Ethics and Regulatory Compliance:
The study follows European regulations on data protection and ethical standards. Informed
consent will be obtained from all participants, and the Fundació Vall d'Hebron Institut
de Recerca (VHIR) acts as the study sponsor.
Timeline:
The patient inclusion period is expected to last 18 months, followed by 3 months of
follow-up, and 2 months for data analysis.