Identification of Brain Injury Using Portable MRI

NCT ID: NCT07197918

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-04-30

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.

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

Conditions

Cardiac Arrest (CA); Hypoxic-Ischemic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

portable MRI scanner

Intervention Type: DEVICE

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

Interventions

portable MRI scanner

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Beekman, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Beekman, MD

Role: CONTACT

Phone: 516-965-4251

Email: rachel.beekman@yale.edu

Emily Gilmore, MD, MS

Role: CONTACT

Phone: 203-314-0555

Email: emily.gilmore@yale.edu

Other Identifiers

1R21NS145048-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000040339

Identifier Type: -

Identifier Source: org_study_id