Cardiac Arrest (CA)NCT07197918
Identification of Brain Injury Using Portable MRI
An observational study of Cardiac Arrest (CA) and Hypoxic-Ischemic Brain Injury, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest (CA), Hypoxic-Ischemic Brain Injury
- What is being tested?
- portable MRI scanner
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2025to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Comatose adult survivors of out-of-hospital cardiac arrest, treated with temperature control will be enrolled in the emergency department or intensive care unit.
Who may be able to join
- Unresponsive immediately after ROSC from IHCA or OHCA
- Age ≥ 18 years of age
- Conventional MRI is clinically indicated
- Treatment with temperature control
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 05620
About this study
Official title: Prospective Identification of Hypoxic Ischemic Brain Injury Using Portable Magnetic Resonance Imaging
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.
Read the 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:
- 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.
- 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):
- 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
- Conditions
- Cardiac Arrest (CA), Hypoxic-Ischemic Brain Injury
- Being tested
- portable MRI scanner
- Medical subject headings
- Heart Arrest, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
portable MRI scannerDevice
Participants will receive 2-3 portable MRI scans: <6 hours, 6-24 hours, and within 12 (+/- 12) hours of conventional MRI
| Study group | Role | What they receive |
|---|---|---|
| Cardiac arrest with Return of Spontaneous Circulation (ROSC) | All enrolled patients will have two to three portable MRIs ( <6 hours, 6-24 hours and one within 12 (+/- 12) hours of conventional MRI) and one conventional MRI. Standard of care will occur per the clinical team and this study will not interfere with standard of care. Receives: Device: portable MRI scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortex- DGN HIBI score
Hypoxic ischemic brain injury will be assessed using the Cortex- DGN HIBI score on a scale of 0-40. Higher scores indicate greater injury.
Measured: up to 6 hours post cardiac arrest, up to 24 hours post cardiac arrest and within 12 (+/- 12) hours of conventional MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start2 Dec 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Beekman, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197918
- Sponsor's protocol ID
- 2000040339
- Other IDs
- 1R21NS145048-01
- Status last verified
- Jan 2026
- First submitted
- 26 Sep 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: This project will produce a prospective clinical database and an MRI repository, including serial low-field MRI and a single conventional standard of care MRI. De-identified data will be made available for submission to the NINDS data repository or elsewhere as arranged with the Institute. Data will also be submitted to OpenNeuro
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Identification of Hypoxic Ischemic Brain Injury Using Portable Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT07197918
- Acronym / sponsor ID
- 2000040339
- Conditions
- Cardiac Arrest (CA), Hypoxic-Ischemic Brain Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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):
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac arrest with Return of Spontaneous Circulation (ROSC) | – | Device: portable MRI scannerAll enrolled patients will have two to three portable MRIs ( <6 hours, 6-24 hours and one within 12 (+/- 12) hours of conventional MRI) and one conventional MRI. Standard of care will occur per the clinical team and this study will not interfere with standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Comatose adult survivors of out-of-hospital cardiac arrest, treated with temperature control will be enrolled in the emergency department or intensive care unit.
Key inclusion criteria (4 listed)
- Unresponsive immediately after ROSC from IHCA or OHCA
- Age ≥ 18 years of age
- Conventional MRI is clinically indicated
- Treatment with temperature control
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| portable MRI scannerParticipants will receive 2-3 portable MRI scans: <6 hours, 6-24 hours, and within 12 (+/- 12) hours of conventional MRI | Device | Cardiac arrest with Return of Spontaneous Circulation (ROSC) |
Primary outcome
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
Hypoxic ischemic brain injury will be assessed using the Cortex- DGN HIBI score on a scale of 0-40. Higher scores indicate greater injury.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Yes. This project will produce a prospective clinical database and an MRI repository, including serial low-field MRI and a single conventional standard of care MRI. De-identified data will be made available for submission to the NINDS data repository or elsewhere as arranged with the Institute. Data will also be submitted to OpenNeuro
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Beekman, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest (CA) and Hypoxic-Ischemic Brain Injury, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Beekman, MD (516-965-4251, rachel.beekman@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.