In-hospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta
NCT07434726
Cardiac Arrest, Cardiovascular Diseases
Bern, Switzerland
View Trial DetailsNCT Number: NCT06423768
The goal of this observational study is to determine whether specific advanced MRI measures are associated with functional outcomes in patients who are comatose after cardiac arrest. The main question[s] it aims to answer are:
Aim 1: Determine if stimulus-based functional MRI (fMRI)-measured activations are independently associated with favorable neurological outcomes after cardiac arrest
Aim 2: Determine if resting state functional MRI (rs-fMRI)-measured functional network connectivity is independently associated with favorable neurological outcomes after cardiac arrest.
Aim 3: Determine if diffusion tensor imaging (DTI)-measured white matter integrity is associated with favorable neurological outcomes after cardiac arrest.
Participants will undergo advanced MRI sequences at time of clinical MRI, and will be followed for 6 months post-arrest.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Brigham and Women's Hospital, Boston, Massachusetts, United States
Our goal here is to determine whether advanced functional MRI and DTI sequences add actionable prognostic information relative to standard clinical MRI in patients who remain comatose after cardiac arrest. We plan the following specific analyses:
Aim 1: We will use logistic regression to measure the association between our primary outcome and fMRI BOLD response to (a) passive language stimuli, (b) motor imagery or (c) passive sensory stimuli, in a model with age, Glasgow Coma Scale (GCS) score at time of MRI, and presence of anoxic injury on clinical diffusion weighted MRI.
Aim 2: We will use logistic regression to measure the association between our primary outcome and default mode network resting state functional connectivity, in a model with age, Glasgow Coma Scale (GCS) score at time of MRI, and presence of anoxic injury on clinical diffusion weighted MRI.
Aim 3: We will use logistic regression to measure the association between our primary outcome and diffusion tensor imaging (DTI)-measured mean white matter fractional anisotropy, in a model with age, Glasgow Coma Scale (GCS) score at time of MRI, and presence of anoxic injury on clinical diffusion weighted MRI.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 months
A standardized scale describing a patients overall level of independent function. Ranges from 1 (asymptomatic) to 5 (death). Levels 1-2 reflect patients who are functionally independent in their iADLs.
Time frame: 2 weeks
Any patient who has recovered consciousness (follows verbal commands), regardless of their disability level at 2-weeks
Contact information is provided by the study sponsor or research team.
Brigham and Women's Hospital
Other
The fMRI in CardiaC arrEst With Uncertain Prognosis (FACE-UP) Study
Acronym: FACE-UP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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