<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03308305</url>
  </required_header>
  <id_info>
    <org_study_id>2017-1006</org_study_id>
    <nct_id>NCT03308305</nct_id>
  </id_info>
  <brief_title>Cracking Coma: Towards EEG and MRI Based Precision Medicine After Cardiac Arrest</brief_title>
  <official_title>Cracking Coma: Towards EEG and MRI Based Precision Medicine After Cardiac Arrest</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rijnstate Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Medical Center Nijmegen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Donders Institute for Brain, Cognition and Behaviour</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rijnstate Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: 30-70% of comatose patients admitted to the intensive care unit (ICU) after&#xD;
      cardiac arrest never regain consciousness as a result of post anoxic encephalopathy (PAE).&#xD;
      Early identification of patients without potential for recovery of brain functioning may&#xD;
      prevent inappropriate continuation of medical treatment and improve communication between&#xD;
      doctors and patients. However, current diagnostic and prognostic measures can identify only&#xD;
      20-50% of the patients with irreversible brain damage, precluding cerebral recovery and&#xD;
      awakening. Also, the pathophysiology of brain damage is largely unclear. New magnetic&#xD;
      resonance imaging (MRI) sequences hold potential to substantially improve outcome prediction.&#xD;
&#xD;
      Objectives: 1. To estimate the additional value of early MRI monitoring for the prediction of&#xD;
      neurological outcome of comatose patients after cardiac arrest. 2. To gain insight in the&#xD;
      pathophysiology of PAE by associating MRI findings with histopathological studies of brain&#xD;
      tissue obtained from non-survivors.&#xD;
&#xD;
      Study design: prospective cohort study.&#xD;
&#xD;
      Study population: 100 subsequent comatose patients after cardiac arrest, admitted to the ICU.&#xD;
&#xD;
      Intervention: In addition to standard treatments, patients will undergo MRI of the brain at&#xD;
      day 3, 7, and three months after cardiac arrest. A subgroup of patients will be scanned&#xD;
      within 24 hours after cardiac arrest, to assess feasibility and to gain more insight in the&#xD;
      evolution of brain damage in PAE. Survivors will be followed for one year. Outcome&#xD;
      measurements will focus on disabilities, quality of life, and depression. MRI measures will&#xD;
      be related to outcome.&#xD;
&#xD;
      Main study parameters/endpoints: The primary outcome measure is neurological outcome, defined&#xD;
      as the score on the Cerebral Performance Category (CPC) at six months, dichotomized as good&#xD;
      (CPC 1-2 = no or moderate neurological disability) or poor (CPC 3-5 = severe disability,&#xD;
      coma, or death). Secondary outcome measures include cognitive functioning, depression, and&#xD;
      quality of life at one year, as well as histopathological damage of brain tissue of&#xD;
      non-survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Standard procedures:&#xD;
&#xD;
      Patients will be monitored and treated according to guidelines for post out of hospital&#xD;
      cardiac arrest treatment as described in local ICU protocols. Patients do not suffer any&#xD;
      harm, disadvantage of discomfort while participating in this study.&#xD;
&#xD;
      Standard treatment includes targeted temperature management, hemodynamic monitoring and&#xD;
      stabilisation, continuous EEG monitoring, blood sampling through the jugular bulb catheter,&#xD;
      Near Infrared Spectroscopy (NIRS), and transcranial doppler (TCD) measurements. The patient's&#xD;
      status is repeatedly assessed and treatment is based on the clinical findings.&#xD;
&#xD;
      Additional procedures:&#xD;
&#xD;
        1. MRI A total of 3 MRI scans is planned for each patient: at day 3 ± 1, and day 7 ± 2&#xD;
           after cardiac arrest, and 3 months ± 2 weeks after cardiac arrest. The imaging protocol&#xD;
           will consist of structural MRI (including FLAIR and ADC maps) to detect ischemic damage,&#xD;
           a 3D T1 for structural analysis and SWI sequences to detect micro bleeds), structural&#xD;
           connectivity measurement by DTI, and functional connectivity measurement by resting&#xD;
           state BOLD functional MRI. Estimated time to prepare the patient and transport to and&#xD;
           from the MRI scanner will be approximately 30 minutes, the scan itself will take&#xD;
           approximately 30 minutes, as well. No intravenous contrast agent is used.&#xD;
&#xD;
           1.1 Acute phase MRI To estimate the feasibility of MRI scanning in the acute phase and&#xD;
           to gain more insight in the dynamics of PAE, a subgroup of patients will be scanned&#xD;
           within 24 hours after cardiac arrest. Patients will be included in this subgroup&#xD;
           dependent on availability of the MRI facility, the clinical stability of the patients&#xD;
           and after the patients legal representatives signed informed consent.&#xD;
&#xD;
           1.2 Transport to the radiology department&#xD;
&#xD;
           The transport to and from the radiology department will be performed as described in the&#xD;
           local protocols on patient transportation. Transport to and from other departments is a&#xD;
           frequent procedure in ICU patients. During transport, the patient will be accompanied by&#xD;
           a physician and ICU nurse. The MRI scans for this project will be handled as 'elective',&#xD;
           which indicates that only patients with a stable hemodynamic and respiratory status will&#xD;
           be transported to and undergo the MRI. For this, a patient has to meet all the following&#xD;
           criteria:&#xD;
&#xD;
           A. Hemodynamic stable condition, defined as:&#xD;
&#xD;
             -  mean arterial pressure &gt; 60 mmHg&#xD;
&#xD;
             -  no or low inotropes or vasopressors (dosage norepinephrine &lt; 0,3 ug/kg/min and/or&#xD;
                dobutamine &lt; 10 ug/kg/min or equivalent), dosage adjustments less than 0.1&#xD;
                ug/kg/min in the last hour before MRI&#xD;
&#xD;
           B. Stable cardiac rhythm, defined as:&#xD;
&#xD;
             -  sinus rhythm 50 - 120 beats per minute&#xD;
&#xD;
             -  atrial fibrillation or flutter with ventricle response 60 - 120 per minute&#xD;
&#xD;
           C. Pulmonary stable condition, defined as:&#xD;
&#xD;
             -  Arterial oxygen saturation &gt; 95%&#xD;
&#xD;
             -  maximum fraction inspired oxygen &lt; 60% with maximum level of positive end&#xD;
                expiratory pressure of 10 cm H2O&#xD;
&#xD;
             -  peak inspiratory pressure &lt; 30 cmH2O or &lt;5 l/min oxygen trough nasal cannula (for&#xD;
                patients not on mechanical ventilation)&#xD;
&#xD;
           Mechanical ventilation during transport and scanning will be provided by an MRI&#xD;
           compatible ventilator.&#xD;
&#xD;
           Extensive monitoring of vital functions will not be interrupted during transport or MRI&#xD;
           scanning, by using a mobile trolley with MRI compatible monitoring and ventilation&#xD;
           equipment. At all times, a physician and trained ICU nurse will accompany the patient.&#xD;
           The medical team accompanying the patient can change treatment during transport and&#xD;
           scanning to pursue optimal hemodynamics, pulmonary state, and/or comfort.&#xD;
&#xD;
           1.3 Clinical evaluation of MRI scans All structural MRI scans will be assessed by a&#xD;
           radiologist and results are added to a patient's medical file. Patients and their&#xD;
           families will be informed. However, MRI findings will not be taken into account for&#xD;
           decisions on withdrawal of treatment. BOLD fMRI and DTI data will be analysed later.&#xD;
&#xD;
        2. Outcome At 3 and 6 months, CPC score will be assessed by a telephone interview by a&#xD;
           trained investigator. Additionally, at twelve months, for assessment of cognitive&#xD;
           outcome, depression, quality of life, and care giver strain, the patient will be invited&#xD;
           to the hospital or visited at his / her place of residence. If a patient dies during the&#xD;
           follow-up, the cause of death will be requested from the general practitioner or medical&#xD;
           specialist.&#xD;
&#xD;
        3. Post mortem analysis From all patients that die in the hospital after PAE, permission to&#xD;
           perform autopsy is sought for. Permission will be asked from the legal representative in&#xD;
           the context of current care, after the patient has died. According to current care,&#xD;
           brains will be removed and samples fixated within 24 hours at the local pathology&#xD;
           departments. On samples from 8 brain areas (sensory- and motor cortex, thalamus, basal&#xD;
           ganglia, upper brain stem) evaluation of the agonal state is performed on&#xD;
           hematoxylin-eosin staining. Additionally, predefined sections, including all cortical&#xD;
           layers and white matter, will be formalin fixed for further analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 11, 2018</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Functional outcome</measure>
    <time_frame>6 months after cardiac arrest</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cognitive functioning as defined by professional Neuropsychological examination</measure>
    <time_frame>12 months after cardiac arrest</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of depression</measure>
    <time_frame>12 months after cardiac arrest</time_frame>
    <description>Presence of depression is scored using a Dutch translation of the HADS questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>histopathological damage of brain tissue of non-survivors</measure>
    <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.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early functional outcome</measure>
    <time_frame>At discharge from the ICU and 3 months after cardiac arrest.</time_frame>
    <description>Functional outcome as defined on the Cerebral Performance Category, scored at discharge from the ICU and 3 months after cardiac arrest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participation in society score</measure>
    <time_frame>12 months after cardiac arrest</time_frame>
    <description>The USER-Participate questionnaire will be used to evaluate a subjects participation in society.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L quality of life</measure>
    <time_frame>12 months after cardiac arrest</time_frame>
    <description>Quality of life will be scored by the EQ-5D-5L questionnaire</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Post-Anoxic Coma</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Of patients who die during ICU stay, families are asked permission for autopsy of the brain.&#xD;
      After fixation, multiple fragments of brain tissue will be retained for analysis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of one hundred adult, comatose patients, successfully&#xD;
        resuscitated from cardiac arrest. Generally, these patients are predominantly male and&#xD;
        approximately 60-65 years of age. The patients are by definition at least temporarily&#xD;
        incapacitated.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Comatose, defined as Glasgow Coma Score ≤ 8&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Cardiac arrest with a presumed cardiac cause of the arrest or caused by pulmonary&#xD;
             embolism&#xD;
&#xD;
          -  Admission to ICU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Life expectancy &lt; 24 hours&#xD;
&#xD;
          -  Absence of written informed consent (by a legal representative)&#xD;
&#xD;
          -  Pre-existing dependency in daily living, defined as CPC score 3 or 4&#xD;
&#xD;
          -  Any known progressive brain illness, such as a brain tumor or neurodegenerative&#xD;
             disease.&#xD;
&#xD;
          -  Known contra-indication for MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J Hofmeijer, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rijnstate Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hanneke Keijzer, MSc</last_name>
    <phone>+31 88 005 6402</phone>
    <email>hmkeijzer@rijnstate.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rijnstate Hospital</name>
      <address>
        <city>Arnhem</city>
        <state>Gelderland</state>
        <zip>6815 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hanneke Keijzer, MSc</last_name>
      <phone>+31 (0)88 005 6402</phone>
      <email>HMKeijzer@Rijnstate.nl</email>
    </contact>
    <contact_backup>
      <last_name>Jeannette Hofmeijer, PhD</last_name>
      <phone>+31 (0)88 005 8877</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Radboud University Medical Centre</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hanneke Keijzer, MSc</last_name>
      <phone>+31 (0)88 005 7847</phone>
      <email>Hanneke.Keijzer@radboudumc.nl</email>
    </contact>
    <contact_backup>
      <last_name>C Hoedemaekers, PhD</last_name>
      <phone>+31 (0) 24 361 7273</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marcel Aries, PhD</last_name>
      <email>Marcel.Aries@mumc.nl</email>
    </contact>
    <investigator>
      <last_name>Marcel Aries, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coma</keyword>
  <keyword>Cardiac arrest</keyword>
  <keyword>Prognosis</keyword>
  <keyword>MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coma</mesh_term>
    <mesh_term>Heart Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03308305
org study id: 2017-1006
nct id: NCT03308305
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Functional outcome
time frame: 6 months after cardiac arrest
description: 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)
measure: cognitive functioning as defined by professional Neuropsychological examination
time frame: 12 months after cardiac arrest
description: 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.
measure: Presence of depression
time frame: 12 months after cardiac arrest
description: Presence of depression is scored using a Dutch translation of the HADS questionnaire.
measure: 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.
description: 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.
measure: Early functional outcome
time frame: At discharge from the ICU and 3 months after cardiac arrest.
description: Functional outcome as defined on the Cerebral Performance Category, scored at discharge from the ICU and 3 months after cardiac arrest
measure: Participation in society score
time frame: 12 months after cardiac arrest
description: The USER-Participate questionnaire will be used to evaluate a subjects participation in society.
measure: EQ-5D-5L quality of life
time frame: 12 months after cardiac arrest
description: Quality of life will be scored by the EQ-5D-5L questionnaire
Of patients who die during ICU stay, families are asked permission for autopsy of the brain.
      After fixation, multiple fragments of brain tissue will be retained for analysis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: J Hofmeijer, Dr.
role: Principal Investigator
affiliation: Rijnstate Hospital
last name: Hanneke Keijzer, MSc
phone: +31 88 005 6402
email: hmkeijzer@rijnstate.nl
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Netherlands
responsible party type: Sponsor
mesh term: Coma
mesh term: Heart Arrest
sharing ipd: Undecided