Actively Recruiting

Age: 18Years +
All Genders
NCT05622539

Validate: Trustworthy AI to Improve Acute Stroke Outcomes

Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2024-07-25

218

Participants Needed

3

Research Sites

91 weeks

Total Duration

On this page

Sponsors

H

Hospital Universitari Vall d'Hebron Research Institute

Lead Sponsor

V

VALIDATE CONSORTIUM

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Validate: Trustworthy AI to Improve Acute Stroke Outcomes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • Neuroimaging (CT or MRI) showing signs of acute intracranial hemorrhage
  • Serious, advanced, or terminal illness with anticipated life expectancy less than 3 months
  • Unlikely to be available for 90-day follow-up (e.g., no fixed home address, no telephone, etc.)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Universität Heidelberg

Heidelberg, Germany

Actively Recruiting

2

Hadassah Medical Center

Jerusalem, Israel

Not Yet Recruiting

3

Hospital Vall d'Hebron - VHIR

Barcelona, Catalonia, Spain, 08035

Actively Recruiting

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Research Team

D

Dietmar Frey, MD

CONTACT

M

Malte Von Tottleben

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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