AI-Based Tools for Stroke Diagnosis, Treatment and Outcome Prediction: a Multicentre Prospective Observational Study

Brief summary (registry, in English)

Stroke is a leading cause of death and adult disability. Stroke care is still limited by fragmented care pathways, non-standardised diagnostic work-up and follow-up, and local, non-interoperable data systems across the pre-hospital, in-hospital and post-hospital settings. UMBRELLA-P is a multicentre, prospective, observational study in 7 university hospitals in 6 European countries (Spain, Italy, Belgium, the Netherlands, Germany and Switzerland). Adults with clinically suspected acute stroke or transient ischemic attack (TIA) are managed according to standard of care. Routine clinical, imaging, laboratory, ECG and patient-reported data are collected, pseudonymised, stored on a dedicated server at each hospital and harmonised to the OMOP Common Data Model. The harmonised data form a federated real-world data platform (U-Platform). On this platform, artificial intelligence (AI) models are trained and validated through federated learning, so that no patient data leave the participating sites. The models aim to predict short- and long-term outcomes, reduce time to treatment, and support diagnosis, triage, discharge, follow-up and secondary prevention. Five clinical sub-studies address pre-hospital triage, fast track to reperfusion, emergent intracerebral hemorrhage (ICH) management, TIA/minor stroke, and cardiac evaluation with blood biomarkers. The study is observational. The outputs of the AI models are used for research only and will not influence clinical decisions. Participants are followed for up to 12 months.

What you commit to

• Study type: Observational
• Planned participants: 10000
• From 28 Sept 2026 to the primary completion date, 30 Sept 2029
• 7 sites in 6 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 design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with suspected acute stroke or TIA. They get usual care, and data are collected for research only.

Age

18 years or older

Sex

All sexes can join.

Disease stage

Suspected acute stroke, including TIA. Some parts need symptoms that began less than 24 hours earlier, or bleeding in the brain, or TIA or minor stroke (NIHSS below 7), or an acute ischemic stroke with or without atrial fibrillation.

Main reasons for not taking part

• The record lists no exclusion criteria.

Read by machine on 10 Nov 2026.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Save your city in your profile to sort them by distance.

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