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NCT Number: NCT07526701

Clinical Application of Low-Field Magnetic Resonance Imaging in Patients on Extracorporeal Cardiopulmonary Resuscitation

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).

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Key information

Conditions

Cardiac Arrest (CA) Acute Brain Injury Brain Diseases Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Craniocerebral Trauma Extracorporeal Cardiopulmonary Resuscitation Heart Arrest Heart Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, Beijing Municipality, 100020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Feasibility of 0.23-T MRI examination

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

    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%.

Secondary outcomes

  1. Image Quality

    Time frame: Within 6 hours after the completion of the MRI scan.

    Assessment of the diagnostic quality of 0.23-T MRI images by board-certified neuroradiologists to evaluate noise, artifacts, and anatomical clarity.

  2. Incidence of Acute Brain Injury (ABI)

    Time frame: From the onset of cardiac arrest to the completion of the MRI scan

    The proportion of patients identified with ABI patterns (such as ischemic stroke, intracranial hemorrhage, or cerebral edema) based on 0.23-T MRI findings.

  3. The association between ABI and neurological outcomes

    Time frame: 3 months after ROSC.

    Neurological outcomes were assessed at 3 months after ROSC using the Glasgow-Pittsburgh Cerebral Performance Category (CPC) scale. The CPC scale ranges from 1 to 5, with 1 indicating good performance, 2 indicating moderate disability, 3 indicating severe disability, 4 indicating vegetative state and 5 indicating brain death or death. The neurological outcomes were categorized as favorable prognosis (CPC 1-2) and poor prognosis (CPC 3-5).

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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