Emergency Stroke Unit for Acute Ischemic Stroke Management
Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-C )
PHASE3 · Beijing Tiantan Hospital · NCT06522269
This study is testing if using a special MRI in a new Emergency Stroke Unit can help doctors make quicker and better treatment decisions for people who have just had a stroke.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1622 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital (other) |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06522269 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the outcomes of patients with hyperacute ischemic stroke who arrive at the emergency department within 4.5 hours of symptom onset. Participants will be managed either in a standard stroke unit following established guidelines or in a newly developed Emergency Stroke Unit utilizing low-field magnetic resonance imaging (MRI). The study aims to evaluate the effectiveness of low-field MRI in facilitating timely and accurate treatment decisions for acute stroke. It is a multicenter, week-wise randomized controlled trial designed to provide insights into the potential benefits of this innovative imaging approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years and older who present with ischemic stroke symptoms within 4.5 hours of symptom onset.
Not a fit: Patients who are unable to undergo MRI due to claustrophobia or have contraindications for thrombolysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and outcomes of patients with acute ischemic stroke by enabling faster and more accurate treatment decisions.
How similar studies have performed: Previous studies have shown promise in using low-field MRI for acute stroke diagnosis, suggesting that this approach may be viable and beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years; 2. Patients who arrive at the emergency department within 4.5 hours of symptom onset\* (\*Symptom onset is defined by the "last seen normal" principle); 3. Presenting with ischemic stroke symptoms; 4. Pre-stroke mRS score 0-1; 5. Baseline NIHSS score ≥ 5; 6. Eligible for rt-PA/TNK thrombolysis; 7. Informed consent signed. Exclusion Criteria: 1. Baseline NIHSS score \< 5; 2. Unable to undergo MRI because of claustrophobia; 3. Patients with cardiac pacemaker/brain pacemaker/insulin pump implantation; 4. Definite contraindication for rt-PA/TNK thrombolysis; 5. Patients with postictal hemiparesis (Todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate; 6. Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial; 7. Participation in other interventional randomized clinical trials within 3 months before enrollment; 8. Patients deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.
Where this trial is running
Beijing
- Beijing Tiantan Hospital, Capital Medical University — Beijing, China (RECRUITING)
Study contacts
- Study coordinator: Yongjun Wang
- Email: yongjunwang111@aliyun.com
- Phone: 59978555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemic Stroke, Acute, Emergency stroke unit, Low-field magnetic resonance imaging, Reperfusion therapy