Cardiac ArrestFACE-UPNCT06423768
fMRI in CardiaC arrEst With Uncertain Prognosis
An observational study of Cardiac Arrest, run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 May 2024to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants who have survive a cardiac arrest but remain unresponsive after completion of targeted temperature management (TTM). We will enroll a separate sample of 15 healthy controls to provide a normative range for our advanced MRI imaging measures.
Who may be able to join
- survive of an in or out of hospital cardiac arrest
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Active, not recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
- Recruiting
Brigham and Women's Hospital
Brookline, Massachusetts, 02114
Sam Snider, 9196142137, ssnider@partners.org
About this study
Official title: The fMRI in CardiaC arrEst With Uncertain Prognosis (FACE-UP) Study
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
Read more
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.
Read the 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.
- Conditions
- Cardiac Arrest
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Performance Category Score 1-2
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.
Measured: 6 months
Secondary outcomes (1)
Cerebral Performance Category Score 1-3
Any patient who has recovered consciousness (follows verbal commands), regardless of their disability level at 2-weeks
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start16 May 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Samuel Snider, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423768
- Sponsor's protocol ID
- 2024P000703
- Acronym
- FACE-UP
- Status last verified
- Jun 2026
- First submitted
- 16 May 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to post to openneuro.org
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The fMRI in CardiaC arrEst With Uncertain Prognosis (FACE-UP) Study
- ClinicalTrials.gov ID
- NCT06423768
- Acronym / sponsor ID
- FACE-UP / 2024P000703
- Conditions
- Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 16 May 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have survive a cardiac arrest but remain unresponsive after completion of targeted temperature management (TTM). We will enroll a separate sample of 15 healthy controls to provide a normative range for our advanced MRI imaging measures.
Key inclusion criteria (1 listed)
- survive of an in or out of hospital cardiac arrest
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Cerebral Performance Category Score 1-3
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. Plan to post to openneuro.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel B Snider, MD (857-307-2391, ssnider@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Performance Category Score 1-2 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.