fMRI in CardiaC arrEst With Uncertain Prognosis

ConditionCardiac Arrest

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

survive of an in or out of hospital cardiac arrest

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

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.

Time frame

6 months

Secondary outcomes

Cerebral Performance Category Score 1-3

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

Time frame

2 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

American Heart Association

Collaborator

Source ClinicalTrials.gov

Apply now