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Emergency Stroke Unit for Acute Cerebrovascular Events: A Prospective, Single-arm Trial With a Historical Control Group

Study acronym: ESU-ACE-E
StatusRecruiting
PhaseNot applicable
Started2024-12-02
View on ClinicalTrials.gov ↗
Background Reperfusion therapies, i.e., intravenous thrombolysis (IVT) and/or endovascular thrombectomy (EVT), are most effective treatments in the management of acute ischemic stroke (AIS) patients. The benefits of reperfusion therapies, however, may be reduced by treatment delays due to tests and examinations and logistic issues. Emergency Stroke Unit (ESU), a new concept of stroke unit locating at the Accident and Emergency Department (AED), equipped with a mobile, low-field MR imaging (lfMRI) scanner for fast diagnosis of ischemic stroke, differentiation of intracranial hemorrhage and identification of large vessel occlusion (LVO), is being tested in Mainland China. It may shorten the door-to-needle time (DNT) for IVT and door-to-groin puncture time (DPT) for EVT, which may hance associate with improved functional outcomes of AIS patients. This is a prospective, single-center, open-label, non-randomized, single-arm study aims to evaluate the safety and efficacy of the ESU workflow using lfMRI in shortening the DNT/DPT and improving functional outcomes in AIS patients, who are eligible for IVT and/or EVT and can be treated within 6 hours after onset, compared with standard practice in Hong Kong; to reveal the changes in the ischemic lesions over a few days after IVT/EVT in these patients, with serial follow-up lfMRI exams.

Amendment history 3 changes detected by DataLookout

2026-09-11
critical
Enrollment reduced: 100 → 60 participants
2026-09-11
critical
Primary completion pushed: 2026-12-31 → 2027-12-31
2026-09-11
minor
Completion pushed: 2027-06-30 → 2028-12-31
Trial Details
NCT Number NCT06728592
Lead Sponsor Chinese University of Hong Kong
Collaborators: Beijing Tiantan Hospital
Conditions Ischemic Stroke, Intracerebral Hemorrhage, Stroke, Stroke, Acute, Stroke, Ischemic, Stroke Hemorrhagic, Stroke (CVA) or TIA, Brain Diseases
Enrollment 60 participants
Start Date 2024-12-02
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-10