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NCT Number: NCT06423768

fMRI in CardiaC arrEst With Uncertain Prognosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cerebral Performance Category Score 1-2

    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.

Secondary outcomes

  1. Cerebral Performance Category Score 1-3

    Time frame: 2 weeks

    Any patient who has recovered consciousness (follows verbal commands), regardless of their disability level at 2-weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Samuel B Snider, MD

CONTACT

[email protected]

857-307-2391

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Acronym: FACE-UP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 21, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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