Accelerating Referral for Thrombectomy in Acute Stroke Patients Using an Artificial Intelligence-based Software

NCT06741332 | Recruiting

• 1 other identifier: PR(AG)644-2023
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke; Stroke Acute; Ischemic Stroke, Acute; Thrombectomy

Keywords

Stroke; Ischemic Stroke; Acute stroke; mDIDO; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 1 year

Secondary Outcomes (5)

• Performance evaluation of the NCCT-LVO algorithm for detecting large vessel occlusions (LVO)

  Through study completion, an average of 1 year

• Global reduction of workflow times

  Through study completion, an average of 1 year

• Improvement in treatment rates

  Through study completion, an average of 1 year

• Functional outcome at 90 days

  3 months

• User experience evaluation

  Through study completion, an average of 1 year

Study Arms (2)

Historical cohort

Control group selected retrospectively from each participating center

Other: Normal CT scans evaluation

Prospective cohort

Patients included prospectively after the integration of the Methinks Stroke Suit into the usual stroke care workflow of the participating centers

Device: Methinks software

Interventions

Methinks software DEVICE

Introduction in the stroke code workflow the Methinks AI software capable of detecting LVO on NCCT and CTA, and ICH on NCCT.

Prospective cohort

Normal CT scans evaluation OTHER

The 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.

Historical cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with an acute stroke evaluated in a local stroke center. Sample size is projected to be 250 patients.

You may qualify if:

• 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
• Image has been processed by Methinks Stroke Suite
• Informed consent obtained from a patient or his or her legally designated representative (if locally required).

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Methinks Software SL: collaborator

Study Sites (2)

Hospital General de Manresa Granollers

Granollers, Barcelona, 08402, Spain

RECRUITING

Hospital Vall Hebron

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Marta Olivé

CONTACT

34 93 489 30 00; marta.olive@vallhebron.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 18, 2024
• Study Start: January 27, 2024
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

ES (2)