Beijing Tiantan Hospital, Capital Medical University
Beijing, China
Location status: Recruiting
Location contact
Yongjun Wang, Dr.
CONTACT
NCT Number: NCT06492265
To compare the door-to-puncture time of patients with hyperacute ischemic stroke (between 4.5-6 hours after the onset of symptoms) treated in a standard stroke unit adherent to guidelines versus treated in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Beijing, China
Location status: Recruiting
Yongjun Wang, Dr.
CONTACT
Mechanical thrombectomy is an effective reperfusion therapy for patients with acute ischemic stroke due to large vessel occlusion. Faster door-to-puncture time (DPT) 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-puncture time of patients with hyperacute ischemic stroke (between 4.5-6 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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The participants with hyperacute ischemic stroke (between 4.5-6 hours after onset of symptoms) who are eligible to receive reperfusion therapy will be managed by Emergency Stroke Unit process based on low-field magnetic resonance imaging.
The participants with hyperacute ischemic stroke (between 4.5-6 hours after onset of symptoms) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines.
Time frame: Door-to-puncture time
The time from emergency department arrival to the puncture of endovascular thrombectomy.
Time frame: at 14±2 days (or at discharge, whichever occurs first).
The utility-weighted modified Rankin Scale (uw-mRS) at 14±2 days (or at discharge, whichever occurs first). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).
Time frame: 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). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).
Time frame: 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). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).
Time frame: 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). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).
Time frame: The time from symptoms onset to endovascular thrombectomy decision.
Time frame: The time from emergency department arrival to endovascular thrombectomy decision.
Time frame: Door-to-reperfusion time
The interval between emergency department arrival and the vascular recanalization.
Time frame: within 36 hours.
Symptomatic intracranial hemorrhages within 36 hours (sICH definition: according to the ECASS III criteria: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration, as defined by an increase of 4 points or more in the score on the NIHSS, or that led to death and that was identified as the predominant cause of the neurological deterioration).
Time frame: at 14±2 days (or at discharge, whichever occurs first).
Symptomatic intracranial hemorrhages at 14±2 days (or at discharge, whichever occurs first) (sICH definition: according to the ECASS III criteria: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration, as defined by an increase of 4 points or more in the score on the NIHSS, or that led to death and that was identified as the predominant cause of the neurological deterioration).
Time frame: at 14±2 days (or at discharge, whichever occurs first).
Time frame: at 14±2 days (or at discharge, whichever occurs first).
Time frame: at 14±2 days (or at discharge, whichever occurs first).
Contact information is provided by the study sponsor or research team.
yongjun wang
Other Gov
Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-B )
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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