- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07526701
Clinical Application of Low-Field Magnetic Resonance Imaging in Patients on Extracorporeal Cardiopulmonary Resuscitation
April 9, 2026 updated by: Tang Ziren, Capital Medical University
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).
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100020
- Department of Emergency Medicine, Beijing Chaoyang Hospital, Capital Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability 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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Enrolled patients were those with out-of-hospital cardiac arrest of presumed cardiac cause
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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%. |
From the initiation of the MRI scan until 6 hours after its completion.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within 6 hours after the completion of the MRI scan.
|
|
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.
|
From the onset of cardiac arrest to the completion of the MRI scan
|
|
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).
|
3 months after ROSC.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2024
Primary Completion (Actual)
January 1, 2026
Study Completion (Actual)
January 1, 2026
Study Registration Dates
First Submitted
April 4, 2026
First Submitted That Met QC Criteria
April 9, 2026
First Posted (Actual)
April 13, 2026
Study Record Updates
Last Update Posted (Actual)
April 13, 2026
Last Update Submitted That Met QC Criteria
April 9, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-ke-783
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data supporting the findings of this study could be obtained from the corresponding author upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Brain Injury
-
Allegheny Singer Research Institute (also known...ElectroCore INC; Chuck Noll FoundationCompletedTraumatic Brain Injury | Acute Respiratory Distress Syndrome | Acute Lung Injury | Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)United States
-
Xiangya Hospital of Central South UniversityNot yet recruiting
-
Rigshospitalet, DenmarkCompleted
-
Taichung Tzu Chi HospitalCompleted
-
Rigshospitalet, DenmarkCompleted
-
University of ArizonaCompletedTBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Injuries, Acute BrainUnited States
-
Unity Health TorontoThe Physicians' Services Incorporated FoundationCompletedTBI (Traumatic Brain Injury) | Acute Brain InjuriesCanada
-
Children's Hospital of PhiladelphiaBoston Children's Hospital; University at BuffaloCompletedBrain Concussion | Mild Traumatic Brain Injury | Acute Brain InjuryUnited States
-
Erasme University HospitalFondazione Policlinico Universitario Agostino Gemelli IRCCS; Azienda Ospedaliero... and other collaboratorsRecruitingTraumatic Brain Injury | Acute Brain Injury | Severe Traumatic Brain Injury | Neurocritical CareItaly, Belgium