fMRI in CardiaC arrEst With Uncertain Prognosis

NCT06423768 | Active Not Recruiting

• 1 other identifier: 2024P000703
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• Cerebral Performance Category Score 1-2

  A standardized scale describing a patients overall level of independent function. Levels 1-2 reflect patients who are functionally independent in their iADLs.

  6 months

Secondary Outcomes (1)

• Cerebral Performance Category Score 1-3

  2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• survive of an in or out of hospital cardiac arrest

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• American Heart Association: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: May 16, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)