Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT07197918
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2025-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identification of Brain Injury Using Portable MRI
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Prospective Identification of Hypoxic Ischemic Brain Injury Using Portable Magnetic Resonance Imaging
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R21NS145048-01 | NIH | None | https://reporter.nih.gov/quic… | View |