NCT06492239CompletedPhase 2
Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-A )
Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-A )
Source: ClinicalTrials.gov · Last updated 4 Mar 2025
Brief summary (registry, in English)
To compare the door-to-needle time of patients with hyperacute ischemic stroke (within 4.5 hours after the onset of symptoms) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 218 (actual)
- First submitted
- 1 Jul 2024
- Start date
- 26 Jul 2024
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- Beijing Tiantan Hospital
- Diseases
- Stroke
- NCT number
- NCT06492239
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 218
- From 26 Jul 2024 to the primary completion date, 31 Jan 2025
- 1 site in 1 country
- 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.
Prior treatment
- Patients with postictal hemiparesis (Todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate;
- Participation in other interventional randomized clinical trials within 3 months before enrollment;
Other illness
- Patients with cardiac pacemaker/brain pacemaker/insulin pump implantation;
Other
- Baseline NIHSS score \< 5;
- Unable to undergo MRI because of claustrophobia;
- Definite contraindication for rt-PA/TNK thrombolysis;
- Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial;
- Patients deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.
Who the study is looking for
- Age ≥ 18 years;
- Can be treated within 4.5 hours of symptoms onset\*(\*Symptom onset is defined by the "last seen normal" principle);
- Presenting with ischemic stroke symptoms;
- Pre-stroke mRS score 0-1;
- Baseline NIHSS score ≥ 5;
- Eligible for rt-PA/TNK thrombolysis;
- Informed consent signed.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tiantan Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.