CompletedNot Applicable

Cracking Coma: Towards EEG and MRI Based Precision Medicine After Cardiac Arrest

Netherlands94 participantsStarted 2018-06-11

Plain-language summary

Rationale: 30-70% of comatose patients admitted to the intensive care unit (ICU) after cardiac arrest never regain consciousness as a result of post anoxic encephalopathy (PAE). Early identification of patients without potential for recovery of brain functioning may prevent inappropriate continuation of medical treatment and improve communication between doctors and patients. However, current diagnostic and prognostic measures can identify only 20-50% of the patients with irreversible brain damage, precluding cerebral recovery and awakening. Also, the pathophysiology of brain damage is largely unclear. New magnetic resonance imaging (MRI) sequences hold potential to substantially improve outcome prediction. Objectives: 1. To estimate the additional value of early MRI monitoring for the prediction of neurological outcome of comatose patients after cardiac arrest. 2. To gain insight in the pathophysiology of PAE by associating MRI findings with histopathological studies of brain tissue obtained from non-survivors. Study design: prospective cohort study. Study population: 100 subsequent comatose patients after cardiac arrest, admitted to the ICU. Intervention: In addition to standard treatments, patients will undergo MRI of the brain at day 3, 7, and three months after cardiac arrest. A subgroup of patients will be scanned within 24 hours after cardiac arrest, to assess feasibility and to gain more insight in the evolution of brain damage in PAE. Survivors will be followed for one year. Outcome measurements will focus on disabilities, quality of life, and depression. MRI measures will be related to outcome. Main study parameters/endpoints: The primary outcome measure is neurological outcome, defined as the score on the Cerebral Performance Category (CPC) at six months, dichotomized as good (CPC 1-2 = no or moderate neurological disability) or poor (CPC 3-5 = severe disability, coma, or death). Secondary outcome measures include cognitive functioning, depression, and quality of life at one year, as well as histopathological damage of brain tissue of non-survivors.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Comatose, defined as Glasgow Coma Score ≤ 8 * Age ≥ 18 years * Cardiac arrest with a presumed cardiac cause of the arrest or caused by pulmonary embolism * Admission to ICU Exclusion Criteria: * Pregnancy * Life expectancy \< 24 hours * Absence of written informed consent (by a legal representative) * Pre-existing dependency in daily living, defined as CPC score 3 or 4 * Any known progressive brain illness, such as a brain tumor or neurodegenerative disease. * Known contra-indication for MRI

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial focused on using EEG and MRI to predict outcomes after cardiac arrest-related coma — has the data from this completed study changed how your team uses brain monitoring to guide decisions in cases like mine?
2Since the trial was measuring 'functional outcome,' what does that actually mean in practice — are we talking about ability to walk, communicate, return to daily life — and how do those benchmarks apply to my situation?
3The study combined EEG and MRI as tools for 'precision medicine' after cardiac arrest — does my care team already use both of these, and would the findings from this trial influence how you interpret my results?
4Because this trial is completed, are there published results we could look at together to understand what EEG or MRI patterns were linked to better or worse recovery, and whether any of those patterns are relevant to my case?
5Given that this was a research study rather than a treatment trial, would you say the current standard of care for post-cardiac arrest coma already reflects what was learned here, or are there approaches from this study that aren't yet routine where I'm being treated?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Functional outcome

Timeframe: 6 months after cardiac arrest

Trial details

NCT IDNCT03308305

SponsorRijnstate Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-11-01

View on ClinicalTrials.gov More Post-Anoxic Coma trials