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

NCT06492265 | Recruiting Phase 2 DMC

• 1 other identifier: KY2024-131-02-B
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Ischemic Stroke, Acute

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Door-to-puncture time

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

  Door-to-puncture time

Secondary Outcomes (12)

• 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 time from symptoms onset to endovascular thrombectomy decision.

  The time from symptoms onset to endovascular thrombectomy decision.

Study Arms (2)

Emergency Stroke Unit based on 0.23-T MRI

EXPERIMENTAL

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.

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 (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.

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 (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.

Emergency Stroke Unit based on 0.23-T MRI

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.

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 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;
• Baseline NIHSS score ≥ 5;
• Eligible for endovascular thrombectomy;
• 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 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

• Yongjun Wang: 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, MD, PhD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

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 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: August 4, 2024
• Primary Completion: February 1, 2025
• Study Completion: April 1, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)