Comparing Emergency Stroke Unit Using Low-Field MRI Versus Standard Stroke Unit for Treating Acute Ischemic Stroke Within 4.5 to 6 Hours of Symptom Onset

What this Trial Is About

Researchers are evaluating the door-to-puncture time for patients with hyperacute ischemic stroke occurring between 4.5 to 6 hours after symptom onset. The study compares care in a standard stroke unit that follows established guidelines to care in an Emergency Stroke Unit using low-field magnetic resonance imaging MRI. This phase 2, multicenter, randomized trial aims to determine if the new MRI-based unit can improve treatment timing for stroke patients. Participants eligible for reperfusion therapy will be randomly assigned to receive care either in the Emergency Stroke Unit utilizing 0.23-T MRI or in the standard stroke unit adhering to current guidelines. Both groups consist of patients with hyperacute ischemic stroke within the specified time window. The study will monitor how quickly treatment decisions and procedures, such as endovascular thrombectomy, are initiated in each setting. During the study, patients will be assessed for door-to-puncture time as the primary outcome. Secondary measures include functional outcomes using the modified Rankin Scale at about two weeks or discharge, time to treatment decisions, and safety events like intracranial hemorrhage and mortality within the same timeframe. The trial involves a single-blind design and continuous monitoring of adverse events, with participation spanning from symptom onset through discharge or 14 days.

Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-B )