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Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-B )

ConditionIschemic Stroke, Acute
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYongjun Wang

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

Can be treated between 4.5-6 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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Emergency Stroke Unit based on 0.23-T MRI

    Combination product

    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.

  • Standard stroke unit adherent to guidelines

    Combination product

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Emergency Stroke Unit based on 0.23-T MRIExperimental treatment 1 intervention
Group B: Standard stroke unit adherent to guidelinesPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Door-to-puncture time

The time from emergency department arrival to the puncture of endovascular thrombectomy.

Time frame
Door-to-puncture time

Secondary outcomes

1

The utility-weighted modified Rankin Scale (uw-mRS) 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).
2

Ordinal (shift) analysis of modified Rankin Scale (mRS) 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).
3

Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) 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).
4

Good functional outcome (Modified Rankin Scale score, mRS 0-2) 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
at 14±2 days (or at discharge, whichever occurs first).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yongjun Wang

Lead sponsor

Beijing Tiantan Hospital

Sponsor institution

Source ClinicalTrials.gov
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