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

Beijing Tiantan Hospital1 site in 1 country218 target enrollmentJuly 26, 2024

ConditionsIschemic Stroke, Acute

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Ischemic Stroke, Acute
Sponsor: Beijing Tiantan Hospital
Enrollment: 218
Locations: 1
Primary Endpoint: Door-to-needle time
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Detailed Description

Intravenous thrombolysis is an effective reperfusion therapy for patients with acute ischemic stroke. Faster door-to-needle time (DNT) is associated with significantly better clinical outcomes. With the development of low-field magnetic resonance imaging, it is poised to play an increasingly significant role in the early diagnosis and management of acute ischemic stroke. This prospective, multicenter, week-wise randomized controlled trial will 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).

Registry

clinicaltrials.gov

Start Date

July 26, 2024

End Date

January 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing Tiantan Hospital

Responsible Party

Principal Investigator

Yongjun Wang

professor

Beijing Tiantan Hospital

Eligibility Criteria

Inclusion Criteria

•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.

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 rt-PA/TNK thrombolysis;
•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

Door-to-needle time

Time Frame: Door-to-needle time

The time from emergency department arrival to the start of intravenous thrombolysis.

Secondary Outcomes

The utility-weighted modified Rankin Scale (uw-mRS) at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
Ordinal (shift) analysis of modified Rankin Scale (mRS) at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
The utility-weighted modified Rankin Scale (uw-mRS) at 90±7 days.(at 90±7 days.)
Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90±7 days.(at 90±7 days.)
Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90±7 days.(at 90±7 days.)
Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 90±7 days(at 90±7 days.)
The time from symptoms onset to intravenous thrombolysis decision.(The time from symptoms onset to intravenous thrombolysis decision.)
The time from emergency department arrival to intravenous thrombolysis decision.(The time from emergency department arrival to intravenous thrombolysis decision.)
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 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
Mortality at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
Adverse events at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)
Serious adverse events at 14±2 days (or at discharge, whichever occurs first).(at 14±2 days (or at discharge, whichever occurs first).)