Validation of a Trustworthy AI-based Clinical Decision Support System for Improving Patient Outcome in Acute Stroke Treatment

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Combination product
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Germany
Universität Heidelberg
RECRUITING
Heidelberg
Israel
Hadassah Medical Center
NOT_YET_RECRUITING
Jerusalem
Spain
Hospital Vall d'Hebron - VHIR
RECRUITING
Barcelona
Contact Information
Primary
Dietmar Frey, MD
dietmar.frey@charite.de
+4930450560398
Backup
Malte Von Tottleben
Malte.vonTottleben@empirica.com
Time Frame
Start Date: 2024-07-31
Estimated Completion Date: 2026-05
Participants
Target number of participants: 218
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitari Vall d'Hebron Research Institute
Collaborators: VALIDATE CONSORTIUM

This content was sourced from clinicaltrials.gov