Status:
RECRUITING
Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-D )
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Ischemic Stroke, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 guideline...
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 an...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- 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);
- Presenting with ischemic stroke symptoms;
- Pre-stroke mRS score 0-1;
- Baseline NIHSS score ≥ 5;
- Eligible for endovascular thrombectomy;
- 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 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.
Exclusion
Key Trial Info
Start Date :
August 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06522282
Start Date
August 10 2024
End Date
March 1 2026
Last Update
October 1 2024
Active Locations (1)
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1
Beijing Tiantan Hospital, Capital Medical University
Beijing, China