Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-D )
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Ischemic Stroke, Acute
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- The utility-weighted modified Rankin Scale (uw-mRS) at 90 days (± 7 days).
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
To compare the prognosis of patients with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 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 (arriving at the emergency department between 4.5-6 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).
Investigators
Yongjun Wang
professor
Beijing Tiantan Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Baseline NIHSS score \< 5;
- •Unable to undergo MRI because of claustrophobia;
- •Patients with cardiac pacemaker/brain pacemaker/insulin pump implantation;
- •Definite contraindication for endovascular thrombectomy;
- •Patients with postictal hemiparesis (Todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate;
- •Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial;
- •Participation in other interventional randomized clinical trials within 3 months before enrollment;
- •Patients deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.
Outcomes
Primary Outcomes
The utility-weighted modified Rankin Scale (uw-mRS) at 90 days (± 7 days).
Time Frame: at 90 days (± 7 days).
The utility-weighted modified Rankin Scale (uw-mRS) at 90 days (± 7 days). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).
Secondary Outcomes
- Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90 days (± 7 days).(at 90 days (± 7 days).)
- Excellent functional outcome (modified Rankin Scale score, mRS 0-1) at 90 days (± 7 days).(at 90 days (± 7 days))
- Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 90 days (± 7 days).(at 90 days (± 7 days).)
- A 30% reduction (improvement) from baseline to 24 hours in the NIHSS score.(from baseline to 24 hours in the NIHSS score)
- The time from symptoms onset to endovascular thrombectomy decision.(from baseline to reperfusion therapy)
- The time from emergency department arrival to endovascular thrombectomy decision.(from baseline to reperfusion therapy)
- Proportion of participants ultimately treated with reperfusion therapy.(from baseline to reperfusion therapy)
- The time from emergency department arrival to the puncture of endovascular thrombectomy.(from baseline to reperfusion therapy)
- The cost-effectiveness analysis.(up to 3 months from enrollment.)
- Symptomatic intracranial hemorrhages (according to the ECASS III criteria) within 36 hours.(within 36 hours)
- Symptomatic intracranial hemorrhages (according to the ECASS III criteria) at 90 days (± 7 days).(at 90 days (± 7 days))
- Mortality at 90 days (± 7 days).(at 90 days (± 7 days).)
- Adverse events at 90 days (± 7 days).(at 90 days (± 7 days).)
- Serious adverse events at 90 days (± 7 days).(at 90 days (± 7 days).)