AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicentre, prospective observational study involving seven university hospitals across six European countries. It collects routine clinical, imaging, lab, ECG, and patient-reported data, then harmonises these data to the OMOP Common Data Model. AI models are trained and validated using a federated learning approach so patient data never leave the hospital sites. A retrospective data harmonisation phase precedes prospective validation to test the models on new, independently collected data. The study includes sub-projects focused on pre-hospital triage, rapid reperfusion decisions, emergent intracerebral hemorrhage management, and other stroke-related outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older
* Clinical suspicion of acute stroke (including TIA)
* Written informed consent from the patient or, when not possible, from next of kin; deferred consent is accepted because of the acute setting

Additional inclusion criteria by sub-study:

* WP2 and WP3: suspected stroke according to ambulance personnel or confirmed LVO stroke, AND symptom onset (or last seen well, if unwitnessed) less than 24 hours earlier
* WP4: intracerebral hemorrhage, regardless of sex, risk factors or etiology
* WP5: NIHSS below 7 AND premorbid mRS below 4
* WP6: acute ischemic stroke, with or without atrial fibrillation

Exclusion Criteria:

\* None

Where it's running

• University Hospitals Leuven - KU Leuven
  Leuven, Belgium Recruiting
• Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut de Recerca
  Barcelona, Spain Recruiting
• Universitätsklinikum Hamburg-Eppendorf
  Hamburg, Germany Not yet recruiting
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  Rome, Italy Not yet recruiting
• Amsterdam University Medical Centers
  Amsterdam, Netherlands Not yet recruiting
• Erasmus MC University Medical Center Rotterdam
  Rotterdam, Netherlands Not yet recruiting

Study contacts

• Study coordinator: Carlos Molina
• Email: carlosav.molina@vallhebron.cat
• Phone: +34 677 189 246

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.