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

NCT06522282 | Recruiting Phase 3 DMC

• 1 other identifier: KY2024-131-02-D
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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 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 endovascular thrombectomy decision.

  from baseline to reperfusion therapy

Study Arms (2)

Emergency Stroke Unit based on 0.23-T MRI

EXPERIMENTAL

The participants with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 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 between 4.5-6 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

Interventions

Emergency Stroke Unit based on 0.23-T MRI COMBINATION_PRODUCT

The participants with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 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 COMBINATION_PRODUCT

The participants with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 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 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 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

RECRUITING

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

Central Study Contacts

Yongjun Wang

CONTACT

59978555; yongjunwang111@aliyun.com

Jing Jing

CONTACT

15810312511; jingj_bjttyy@163.com

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: July 1, 2024
• First Posted: July 26, 2024
• Study Start: August 10, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)