Identification of Brain Injury Using Portable MRI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: portable MRI scanner.
- Who it may be relevant to
- Registry conditions: Cardiac Arrest (CA), Hypoxic-Ischemic Brain Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Identification of Hypoxic Ischemic Brain Injury Using Portable Magnetic Resonance Imaging
Overview
The goal of this study is to look for brain injury in patients who had a cardiac arrest, using portable brain imaging. The portable nature of this test will also allow for serial imaging so the investigators can understand how brain injury changes over days. The results of this study may allow for bedside imaging to be available at centers without specialized imaging centers and may identify markers of brain injury that help to select the patients most likely to benefit for clinical trials.
Detailed description
Cardiac arrest occurs when the heart stops beating. This can occur for many reasons ranging from a heart attack to a drug overdose. It claims close to 500,000 lives a year. Even though the heartbeat is restored, blood flow to the brain remains below what is required for normal function. Brain injury is common in patients who had a cardiac arrest and few return to independence. Most patients are in a coma following cardiac arrest. Some patients wake up within the first days to week, but most do not. Physicians rely on tests, such as brain imaging, brain wave tests, and lab tests to help predict recovery. Magnetic resonance imaging is a type of brain test used to look for injury to the brain. This type of imaging is not available in community centers and requires transport out of the intensive care unit. Transport can be dangerous in patients who are on life support. New tools have been developed that allow for imaging at the bedside.
These portable machines allow patients to stay connected to all necessary monitoring and decrease interruptions in treatment.
Primary Objective:
A. To evaluate inter-rater agreement of low-field portable MRI as compared to high-field conventional MRI for measuring hypoxic ischemic brain injury severity, using a qualitative MRI scoring system.
B. To acquire early low-field portable MRI (\<6 and \<24 hours from cardiac arrest) to establish the specificity and positive predictive value of early DWI lesions for predicting hypoxic ischemic brain injury on later conventional MRI.
Secondary Objectives (if applicable):
i. To characterize changes in the regions affected and severity of hypoxic ischemic brain injury on MRI over time.
ii. To identify the impact of early DWI lesions on neurologic prognosis iii. To quantify the incidence of early DWI lesions in post-cardiac arrest patients iv. To describe the feasibility of serial portable MRI in post-cardiac arrest patients
Interventions
- Device portable MRI scanner
Participants will receive 2-3 portable MRI scans: \<6 hours, 6-24 hours, and within 12 (+/- 12) hours of conventional MRI
Primary outcome measures
- Cortex- DGN HIBI score [Time frame: up to 6 hours post cardiac arrest, up to 24 hours post cardiac arrest and within 12 (+/- 12) hours of conventional MRI]
Eligibility criteria
Inclusion criteria
- Unresponsive immediately after ROSC from IHCA or OHCA
- Age ≥ 18 years of age
- Conventional MRI is clinically indicated
- Treatment with temperature control
Exclusion criteria
- MRI contraindication according to the American Heart Association guidelines
- Inability to tolerate supine positioning for 30 minutes
- Diffuse loss of grey-white differentiation and sulcal effacement on head computed tomography within 6 hours of ROSC
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Yale New Haven Hospital — New Haven
Identifiers
NCT: NCT07197918 · 2000040339 · 1R21NS145048-01