Clinical trial NCT06522269: Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-C )
Official title: Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-C )
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ischemic Stroke, Acute
Keywords: Emergency stroke unit
Low-field magnetic resonance imaging
Reperfusion therapy
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 1622
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the prognosis of patients with hyperacute ischemic stroke (who arrive at the emergency department within 4.5 hours of symptom onset) 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).

Detailed description: The first MRI machines in the 1970s and 1980s were low-field due to technological limitations. As technology advanced, the focus shifted to higher field strengths to achieve better image resolution and faster scan times. Recently, there has been renewed interest in low-field MRI due to advancements in hardware and software, making them more viable for specific clinical applications, including acute stroke. Prompt and accurate imaging is crucial for diagnosing ischemic stroke and determining the appropriate treatment (e.g., thrombolysis or thrombectomy). Research has demonstrated that low-field MRI can effectively detect acute ischemic changes and distinguish between ischemic and hemorrhagic stroke. By providing accessible, cost-effective, and safe imaging, it can facilitate timely and accurate treatment, particularly in settings where high-field MRI is not readily available. This prospective, multicenter, week-wise randomized controlled trial will compare the prognosis of patients with hyperacute ischemic stroke (who arrive at the emergency department within 4.5 hours of symptom onset) 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).

Eligibility 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.

Primary outcomes:
measure: The utility-weighted modified Rankin Scale (uw-mRS) at 90 days (± 7 days).
timeFrame: at 90 days (± 7 days)
Secondary outcomes:
measure: Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90 days (± 7 days).
timeFrame: at 90 days (± 7 days)
measure: Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90 days (± 7 days).
timeFrame: at 90 days (± 7 days)
measure: Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 90 days (± 7 days).
timeFrame: at 90 days (± 7 days)
measure: A 30% reduction (improvement) from baseline to 24 hours in the NIHSS score.
timeFrame: from baseline to 24 hours in the NIHSS score.
measure: The time from symptoms onset to intravenous thrombolysis decision.
timeFrame: up to 4.5 hours from symptom onset
measure: The time from emergency department arrival to intravenous thrombolysis decision.
timeFrame: up to 4.5 hours from symptom onset.
measure: Proportion of participants ultimately treated with reperfusion therapy (separated rate of intravenous thrombolysis / endovascular thrombectomy / bridging therapy).
timeFrame: up to 6 hours from symptom onset.
measure: The time from emergency department arrival to the start of intravenous thrombolysis.
timeFrame: up to 4.5 hours from symptom onset
measure: The cost-effectiveness analysis.
timeFrame: up to 3 months from enrollment.
measure: Symptomatic intracranial hemorrhages (according to the ECASS III criteria) within 36 hours.
timeFrame: within 36 hours.
measure: Symptomatic intracranial hemorrhages (according to the ECASS III criteria) at 90 days (± 7 days).
timeFrame: at 90 days (± 7 days).
measure: Mortality at 90 days (± 7 days).
timeFrame: at 90 days (± 7 days).
measure: Adverse events at 90 days (± 7 days).
timeFrame: at 90 days (± 7 days).
measure: Serious adverse events at 90 days (± 7 days).
timeFrame: at 90 days (± 7 days).
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yongjun Wang
role: STUDY_DIRECTOR
References: