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

January 28, 2026 updated by: Rijnstate Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Standard procedures:

Patients will be monitored and treated according to guidelines for post out of hospital cardiac arrest treatment as described in local ICU protocols. Patients do not suffer any harm, disadvantage of discomfort while participating in this study.

Standard treatment includes targeted temperature management, hemodynamic monitoring and stabilisation, continuous EEG monitoring, blood sampling through the jugular bulb catheter, Near Infrared Spectroscopy (NIRS), and transcranial doppler (TCD) measurements. The patient's status is repeatedly assessed and treatment is based on the clinical findings.

Additional procedures:

  1. MRI A total of 3 MRI scans is planned for each patient: at day 3 ± 1, and day 7 ± 2 after cardiac arrest, and 3 months ± 2 weeks after cardiac arrest. The imaging protocol will consist of structural MRI (including FLAIR and ADC maps) to detect ischemic damage, a 3D T1 for structural analysis and SWI sequences to detect micro bleeds), structural connectivity measurement by DTI, and functional connectivity measurement by resting state BOLD functional MRI. Estimated time to prepare the patient and transport to and from the MRI scanner will be approximately 30 minutes, the scan itself will take approximately 30 minutes, as well. No intravenous contrast agent is used.

    1.1 Acute phase MRI To estimate the feasibility of MRI scanning in the acute phase and to gain more insight in the dynamics of PAE, a subgroup of patients will be scanned within 24 hours after cardiac arrest. Patients will be included in this subgroup dependent on availability of the MRI facility, the clinical stability of the patients and after the patients legal representatives signed informed consent.

    1.2 Transport to the radiology department

    The transport to and from the radiology department will be performed as described in the local protocols on patient transportation. Transport to and from other departments is a frequent procedure in ICU patients. During transport, the patient will be accompanied by a physician and ICU nurse. The MRI scans for this project will be handled as 'elective', which indicates that only patients with a stable hemodynamic and respiratory status will be transported to and undergo the MRI. For this, a patient has to meet all the following criteria:

    A. Hemodynamic stable condition, defined as:

    • mean arterial pressure > 60 mmHg
    • no or low inotropes or vasopressors (dosage norepinephrine < 0,3 ug/kg/min and/or dobutamine < 10 ug/kg/min or equivalent), dosage adjustments less than 0.1 ug/kg/min in the last hour before MRI

    B. Stable cardiac rhythm, defined as:

    • sinus rhythm 50 - 120 beats per minute
    • atrial fibrillation or flutter with ventricle response 60 - 120 per minute

    C. Pulmonary stable condition, defined as:

    • Arterial oxygen saturation > 95%
    • maximum fraction inspired oxygen < 60% with maximum level of positive end expiratory pressure of 10 cm H2O
    • peak inspiratory pressure < 30 cmH2O or <5 l/min oxygen trough nasal cannula (for patients not on mechanical ventilation)

    Mechanical ventilation during transport and scanning will be provided by an MRI compatible ventilator.

    Extensive monitoring of vital functions will not be interrupted during transport or MRI scanning, by using a mobile trolley with MRI compatible monitoring and ventilation equipment. At all times, a physician and trained ICU nurse will accompany the patient. The medical team accompanying the patient can change treatment during transport and scanning to pursue optimal hemodynamics, pulmonary state, and/or comfort.

    1.3 Clinical evaluation of MRI scans All structural MRI scans will be assessed by a radiologist and results are added to a patient's medical file. Patients and their families will be informed. However, MRI findings will not be taken into account for decisions on withdrawal of treatment. BOLD fMRI and DTI data will be analysed later.

  2. Outcome At 3 and 6 months, CPC score will be assessed by a telephone interview by a trained investigator. Additionally, at twelve months, for assessment of cognitive outcome, depression, quality of life, and care giver strain, the patient will be invited to the hospital or visited at his / her place of residence. If a patient dies during the follow-up, the cause of death will be requested from the general practitioner or medical specialist.
  3. Post mortem analysis From all patients that die in the hospital after PAE, permission to perform autopsy is sought for. Permission will be asked from the legal representative in the context of current care, after the patient has died. According to current care, brains will be removed and samples fixated within 24 hours at the local pathology departments. On samples from 8 brain areas (sensory- and motor cortex, thalamus, basal ganglia, upper brain stem) evaluation of the agonal state is performed on hematoxylin-eosin staining. Additionally, predefined sections, including all cortical layers and white matter, will be formalin fixed for further analyses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Center
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 AD
        • Rijnstate Hospital
      • Nijmegen, Gelderland, Netherlands
        • Radboud University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of one hundred adult, comatose patients, successfully resuscitated from cardiac arrest. Generally, these patients are predominantly male and approximately 60-65 years of age. The patients are by definition at least temporarily incapacitated.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional outcome
Time Frame: 6 months after cardiac arrest
Functional outcome as defined on the Cerebral Performance Category , dichotomized as good (CPC 1-2 = no or moderate neurological disability) or poor (CPC 3-5 = severe disability, coma, or death)
6 months after cardiac arrest

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
cognitive functioning as defined by professional Neuropsychological examination
Time Frame: 12 months after cardiac arrest
By using a standardized Neuropsychological examination, the cognitive state of a patient will be assessed one year after the cardiac arrest. The examination will focus on memory, language, executive functioning, speed of information processing, concentration and attention and visuoconstruction.
12 months after cardiac arrest
Presence of depression
Time Frame: 12 months after cardiac arrest
Presence of depression is scored using a Dutch translation of the HADS questionnaire.
12 months after cardiac arrest
histopathological damage of brain tissue of non-survivors
Time Frame: Autopsy will take place at the first workday after the patient died at the ICU after cardiac arrest. After 2 weeks, the brain will be cut and paraffine coupes will be made. Analyses of the coupes will take place in batches.
After fixation, histopathological staining will be performed on gray matter and white matter structures of the brain. Different stainings will be used to asses morphological damage, synaptic damage and membrane damage.
Autopsy will take place at the first workday after the patient died at the ICU after cardiac arrest. After 2 weeks, the brain will be cut and paraffine coupes will be made. Analyses of the coupes will take place in batches.
Early functional outcome
Time Frame: At discharge from the ICU and 3 months after cardiac arrest.
Functional outcome as defined on the Cerebral Performance Category, scored at discharge from the ICU and 3 months after cardiac arrest
At discharge from the ICU and 3 months after cardiac arrest.
Participation in society score
Time Frame: 12 months after cardiac arrest
The USER-Participate questionnaire will be used to evaluate a subjects participation in society.
12 months after cardiac arrest
EQ-5D-5L quality of life
Time Frame: 12 months after cardiac arrest
Quality of life will be scored by the EQ-5D-5L questionnaire
12 months after cardiac arrest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rijnstate Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maastricht University Medical Center
University Medical Center Nijmegen
Donders Centre for Cognitive Neuroimaging

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: J Hofmeijer, PhD, Rijnstate Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-1006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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