New emergency stroke unit using low-field MRI for acute ischemic stroke treatment

Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-D )

This study is testing whether treating patients with a new low-field MRI in an emergency stroke unit can lead to better outcomes compared to standard care for those who have had a stroke within 4.5 to 6 hours.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06522282 on ClinicalTrials.gov

What this trial studies

This clinical trial compares the outcomes of patients with hyperacute ischemic stroke who are treated in a standard stroke unit versus those managed in a newly established Emergency Stroke Unit that utilizes low-field magnetic resonance imaging (MRI). The study focuses on patients arriving at the emergency department between 4.5 to 6 hours after symptom onset, aiming to determine if low-field MRI can enhance timely and accurate treatment decisions. By leveraging advancements in low-field MRI technology, the trial seeks to improve the diagnosis and management of acute ischemic strokes, particularly in settings where high-field MRI is not available. This multicenter, randomized controlled trial will provide valuable insights into the effectiveness of this innovative approach.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who present with ischemic stroke symptoms within 4.5 to 6 hours of symptom onset and are eligible for endovascular thrombectomy.

Not a fit: Patients with a baseline NIHSS score less than 5 or those unable to undergo MRI due to claustrophobia or other contraindications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved outcomes for patients suffering from acute ischemic strokes by facilitating faster and more accurate treatment.

How similar studies have performed: While the use of low-field MRI in acute stroke management is gaining interest, this specific approach is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

1. Age ≥ 18 years;
2. Patients who arrive at the emergency department between 4.5-6 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 endovascular thrombectomy;
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 endovascular thrombectomy;
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

Conditions: Ischemic Stroke, Acute, Emergency stroke unit, Low-field magnetic resonance imaging, Reperfusion therapy