Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-29 @ 11:42 PM
Study NCT ID:
NCT06423768
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
fMRI in CardiaC arrEst With Uncertain Prognosis
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
The fMRI in CardiaC arrEst With Uncertain Prognosis (FACE-UP) Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
FACE-UP
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: