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fMRI in CardiaC arrEst With Uncertain Prognosis

The fMRI in CardiaC arrEst With Uncertain Prognosis (FACE-UP) Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06423768
Acronym
FACE-UP
Enrollment
50
Registered
2024-05-21
Start date
2024-05-16
Completion date
2027-12-01
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

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.

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.

Interventions

None listed

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER
American Heart Association
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* survive of an in or out of hospital cardiac arrest

Exclusion criteria

* Drug overdose * Opinion of medical team patient unlikely to survive more than 24 hours (severe concurrent medical illness, dilated and unreactive pupils, etc..) * Following verbal commands (MD or RN note) once TTM is complete and normothermia is achieved (Day 2 or 3; Day of admission is Hospital Day 0). If no TTM is administered, this can be assessed on Hospital Day 2. * Following verbal commands (study team assessment) at time of MRI * Family planning to WLST at time of enrollment * Non English speaker (okay if English not primary language, as long as they can understand it) * Permanent Contraindication to MRI (some kind of implanted metal) * Pregnant

Design outcomes

Primary

MeasureTime frameDescription
Cerebral Performance Category Score 1-26 monthsA 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.

Secondary

MeasureTime frameDescription
Cerebral Performance Category Score 1-32 weeksAny patient who has recovered consciousness (follows verbal commands), regardless of their disability level at 2-weeks

Countries

United States

Contacts

CONTACTSamuel B Snider, MD
ssnider@bwh.harvard.edu857-307-2391

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026