Identification of Brain Injury Using Portable MRI
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Unresponsive immediately after ROSC from IHCA or OHCA
Age ≥ 18 years of age
Conventional MRI is clinically indicated
Treatment with temperature control
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
portable MRI scanner
DeviceParticipants will receive 2-3 portable MRI scans: \<6 hours, 6-24 hours, and within 12 (+/- 12) hours of conventional MRI
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Cardiac arrest with Return of Spontaneous Circulation (ROSC)1 intervention
Trial outcomes
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.
Time frame
up to 6 hours post cardiac arrest, up to 24 hours post cardiac arrest and within 12 (+/- 12) hours of conventional MRISponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov