NCT05622539Completed
Validate: Trustworthy AI to Improve Acute Stroke Outcomes
Validation of a Trustworthy AI-based Clinical Decision Support System for Improving Patient Outcome in Acute Stroke Treatment
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 289 (actual)
- First submitted
- 29 Oct 2022
- Start date
- 31 Jul 2024
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Diseases
- Stroke
- NCT number
- NCT05622539
What you commit to
- Study type: Observational
- Participants enrolled: 289
- From 31 Jul 2024 to the primary completion date, 28 Feb 2026
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Neuroimaging (CT/MRI) with signs of acute intracranial haemorrhage
- Serious, advanced, or terminal illness with anticipated life expectancy of less than 3 months
Other
- Unlikely to be available for 90-day follow-up (e.g., no fixed home address, no telephone, etc.)
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universität Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Hospital Vall d'Hebron - VHIR Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.