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

NCT06522269 | Completed Phase 3 DMC

• 1 other identifier: KY2024-131-02-C
• Study Type: interventional
• Target: 1,622
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the prognosis of patients with hyperacute ischemic stroke (who arrive at the emergency department within 4.5 hours of symptom onset) 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).

Conditions

Ischemic Stroke, Acute

Keywords

Emergency stroke unit; Low-field magnetic resonance imaging; Reperfusion therapy

Outcome Measures

Primary Outcomes (1)

• The utility-weighted modified Rankin Scale (uw-mRS) at 90 days (± 7 days).

  The utility-weighted modified Rankin Scale (uw-mRS) at 90 days (± 7 days). Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).

  at 90 days (± 7 days)

Secondary Outcomes (14)

• Ordinal (shift) analysis of modified Rankin Scale (mRS) at 90 days (± 7 days).

  at 90 days (± 7 days)

• Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90 days (± 7 days).

  at 90 days (± 7 days)

• Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 90 days (± 7 days).

  at 90 days (± 7 days)

• A 30% reduction (improvement) from baseline to 24 hours in the NIHSS score.

  from baseline to 24 hours in the NIHSS score.

• The time from symptoms onset to intravenous thrombolysis decision.

  up to 4.5 hours from symptom onset

Study Arms (2)

Emergency Stroke Unit based on 0.23-T MRI

EXPERIMENTAL

The participants with hyperacute ischemic stroke (arriving at the emergency department within 4.5 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by Emergency Stroke Unit process based on low-field magnetic resonance imaging.

Combination Product: Emergency Stroke Unit based on 0.23-T MRI

Standard stroke unit adherent to guidelines

PLACEBO COMPARATOR

The participants with hyperacute ischemic stroke (arriving at the emergency department within 4.5 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines.

Combination Product: Standard stroke unit adherent to guidelines

Interventions

Emergency Stroke Unit based on 0.23-T MRI COMBINATION_PRODUCT

The participants with hyperacute ischemic stroke (arriving at the emergency department within 4.5 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by Emergency Stroke Unit process based on low-field magnetic resonance imaging.

Emergency Stroke Unit based on 0.23-T MRI

Standard stroke unit adherent to guidelines COMBINATION_PRODUCT

The participants with hyperacute ischemic stroke (arriving at the emergency department within 4.5 hours of symptom onset) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines.

Standard stroke unit adherent to guidelines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Patients who arrive at the emergency department within 4.5 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 rt-PA/TNK thrombolysis;
• Informed consent signed.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yongjun Wang

  Beijing Tiantan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 26, 2024
• Study Start: August 8, 2024
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: August 22, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)