Identification of Brain Injury Using Portable MRI

NCT07197918 | Recruiting FDA Device

• 2 other identifiers: 20000403391R21NS145048-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiac Arrest (CA); Hypoxic-Ischemic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 6 hours post cardiac arrest, up to 24 hours post cardiac arrest and within 12 (+/- 12) hours of conventional MRI

Study Arms (1)

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.

Device: portable MRI scanner

Interventions

portable MRI scanner DEVICE

Participants will receive 2-3 portable MRI scans: \<6 hours, 6-24 hours, and within 12 (+/- 12) hours of conventional MRI

Cardiac arrest with Return of Spontaneous Circulation (ROSC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Unresponsive immediately after ROSC from IHCA or OHCA
• Age ≥ 18 years of age
• Conventional MRI is clinically indicated
• Treatment with temperature control

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 05620, United States

RECRUITING

MeSH Terms

Conditions

Heart Arrest; Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel Beekman, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Beekman, MD

CONTACT

516-965-4251; rachel.beekman@yale.edu

Emily Gilmore, MD, MS

CONTACT

203-314-0555; emily.gilmore@yale.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: September 30, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The scientific data from this study will be shared as soon as possible and no later than the time of an associated publication or the end of the performance period, whichever comes first. Once submitted to the repository, OpenNeuro will manage its availability for an indefinite period of time.
• Access Criteria: Requests to access the shared data after the trial is completed will be handled by the NINDS data repository.

Locations

US (1)