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

NCT06492239 | Completed Phase 2 DMC

• 1 other identifier: KY2024-131-02-A
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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 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; Intravenous thrombolysis

Outcome Measures

Primary Outcomes (1)

• Door-to-needle time

  The time from emergency department arrival to the start of intravenous thrombolysis.

  Door-to-needle time

Secondary Outcomes (15)

• The utility-weighted modified Rankin Scale (uw-mRS) at 14±2 days (or at discharge, whichever occurs first).

  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).

  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).

  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).

  at 14±2 days (or at discharge, whichever occurs first).

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

  at 90±7 days.

Study Arms (2)

Emergency Stroke Unit based on 0.23-T MRI

EXPERIMENTAL

The participants with hyperacute ischemic stroke (symptoms onset ≤4.5 h) 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 (symptoms onset ≤4.5 h) 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 (symptoms onset ≤4.5 h) 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 (symptoms onset ≤4.5 h) 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;
• 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.

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, Beijing Municipality, 100070, 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: July 1, 2024
• First Posted: July 9, 2024
• Study Start: July 26, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: March 4, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)