Validate: Trustworthy AI to Improve Acute Stroke Outcomes
VALIDATE
Validation of a Trustworthy AI-based Clinical Decision Support System for Improving Patient Outcome in Acute Stroke Treatment
2 other identifiers
observational
218
3 countries
3
Brief Summary
Artificial intelligence (AI)-powered prognostic tools and clinical decision support systems can predict the outcome of certain diseases based on a multitude of patient data at high speed, facilitating decisions by healthcare professionals. In acute ischemic stroke, the overall treatment effect and population-wide outcome benefit of treatments such as IV thrombolysis and mechanical thrombectomy are well established. However, in individual patients it is difficult to predict the prognosis in the acute phase of stroke: some patients are candidates for these treatments, but may have poor clinical outcomes (no improvement of stroke or even worsening) Our aim in this study is to validate an artificial intelligence (AI)-based prognostic tool to provide accurate real-time outcome prediction in patients with acute ischemic stroke. During the study, all patients admitted to the emergency room with an acute ischemic stroke will receive the usual treatment for acute stroke in accordance with the stroke neurologists in charge. A "shadow" clinical researcher, without interaction with treating physicians, will collect the data required by the AI model in vivo. These data will be obtained by filling in clinical data through an App on a hospital mobile/tablet, and by a connection with your electronic medical record. The AI models will estimate the outcome of the acute stroke patient, and this prediction will be compared with the real outcome of the patient after 3 months of follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2024
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2022
CompletedFirst Posted
Study publicly available on registry
November 18, 2022
CompletedStudy Start
First participant enrolled
July 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedJuly 25, 2024
July 1, 2024
1.3 years
October 29, 2022
July 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Distribution of functional outcome predicted by real-time AI models measured by mRS
Distribution of functional outcome measured by the modified Rankin scale (mRS) (trichotomized: 0-2, 3-4 and 5-6) predicted by the real-time AI models compared with the real patient's mRS distribution
3 months
Secondary Outcomes (2)
Additional clinician reported (CRO) and patient reported (PRO) outcomes prediction
1 week, 1 month and 3 months
Demonstrate the feasibility of applying AI models in real life
1 day
Interventions
Conventional treatment for acute stroke patients, with or without reperfusion treatments
Eligibility Criteria
Consecutive acute ischemic stroke patients admitted to 3 comprehensive stroke centres during 1.5 years of recruitment
You may qualify if:
- Subject is 18 years of age or older, or of legal age to give informed consent per state or national law
- Informed consent for the use of data, obtained from patient or his or her legally designated representative (if locally required)
You may not qualify if:
- Neuroimaging (CT/MRI) with signs of acute intracranial haemorrhage
- Serious, advanced, or terminal illness with anticipated life expectancy of less than 3 months
- Unlikely to be available for 90-day follow-up (e.g., no fixed home address, no telephone, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Universität Heidelberg
Heidelberg, Germany
Hadassah Medical Center
Jerusalem, Israel
Hospital Vall d'Hebron - VHIR
Barcelona, Catalonia, 08035, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2022
First Posted
November 18, 2022
Study Start
July 31, 2024
Primary Completion
December 1, 2025
Study Completion
May 1, 2026
Last Updated
July 25, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, ANALYTIC CODE
- Time Frame
- The data will be deposited at the end of the project. To ensure commercial exploitation of the results by the consortium the data will be embargoed until 1 year after project end
- Access Criteria
- Metadata of deposited publications will be made openly accessible on the Zenodo repository
The VALIDATE consortium is committed to Open Science and will comply with all mandatory Open Science practices in Horizon Europe (HE) regulated under the Article 17 of the HE General Model Grant Agreement (MGA) v1.0. Additionally, we will implement several recommended Open Science practices. VALIDATE will implement its open science approach according to the "as open as possible, as closed as necessary" principle, maximizing openness in research while protecting intellectual property and commercialisation efforts. Open science will play an integral role within the proposed methodology and will increase the chances of the project delivering on its objectives.