NCT07526701

Brief Summary

Timely identification of acute brain injury (ABI) patterns in patients with extracorporeal cardiopulmonary resuscitation (ECPR) is essential for prognostic assessment and optimization of clinical management, particularly anticoagulation strategies. This study aimed to evaluate the safety and feasibility of early 0.23-T MRI examination in ECPR patients. The investigators further assessed the image quality of the 0.23-T MRI and investigated the incidence and patterns of ABI, as well as their associations with neurological outcomes. This prospective observational study was conducted in the emergency intensive care unit (EICU) of Beijing Chaoyang Hospital, a high-volume ECPR center. The primary outcome was the feasibility of performing 0.23-T MRI in patients undergoing ECPR, defined as successful completion of the examination without serious adverse events (AEs).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

April 4, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

Cardiac ArrestExtracorporeal Cardiopulmonary ResuscitationAcute brain injuryMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • Feasibility of 0.23-T MRI examination

    Defined as the percentage of participants who successfully complete the MRI examination without experiencing serious adverse events (AEs). AEs include a decrease in ECMO flow \> 10%, a change in mean arterial pressure of ± 20%, or a change in minute ventilation \> 20%.

    From the initiation of the MRI scan until 6 hours after its completion.

Secondary Outcomes (3)

  • Image Quality

    Within 6 hours after the completion of the MRI scan.

  • Incidence of Acute Brain Injury (ABI)

    From the onset of cardiac arrest to the completion of the MRI scan

  • The association between ABI and neurological outcomes

    3 months after ROSC.

Study Arms (1)

Enrolled patients were those with out-of-hospital cardiac arrest of presumed cardiac cause

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Enrolled patients were those with out-of-hospital cardiac arrest of presumed cardiac cause, supported by ECPR, who achieved ROSC but remained unconscious and unable to obey verbal commands.

You may qualify if:

  • Enrolled patients were those with out-of-hospital cardiac arrest of presumed cardiac cause, supported by ECPR, who achieved ROSC but remained unconscious and unable to obey verbal commands.

You may not qualify if:

  • age \< 18 years
  • unwitnessed cardiac arrest
  • pregnancy
  • contraindications to MRI (except ECPR, for which safety with 0.23-T MRI has been proved)
  • physical dimensions exceeding scanner limits
  • refusal of consent by the family

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Emergency Medicine, Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Related Publications (1)

  • Suo Y, Du W, Xie X, Jiang Q, Zhang Z, Xu Y, Wei N, Zhu W, Qi N, Wang N, Xue B, Wang Y, Jiang Y, Meng X, Li Z, Zhao X, Li H, Wang Y, Jing J. Detecting acute ischemic lesions using mobile, low-field MRI in TIA and minor stroke in the emergency room. Int J Stroke. 2026 Apr;21(4):475-484. doi: 10.1177/17474930251378850. Epub 2025 Sep 4.

MeSH Terms

Conditions

Heart ArrestBrain Injuries

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 4, 2026

First Posted

April 13, 2026

Study Start

November 1, 2024

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Data supporting the findings of this study could be obtained from the corresponding author upon reasonable request.

Locations