Status:
COMPLETED
Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-A )
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Ischemic Stroke, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT06492239
Start Date
July 26 2024
End Date
January 31 2025
Last Update
March 4 2025
Active Locations (1)
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1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070