<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/NCT03806660</url>
  </required_header>
  <id_info>
    <org_study_id>2018-06Obs-CHRMT</org_study_id>
    <nct_id>NCT03806660</nct_id>
  </id_info>
  <brief_title>Early DiaGnosis of Anoxic Brain Injury for Resuscitated Patients</brief_title>
  <acronym>EDGAR</acronym>
  <official_title>Evaluation of Early Prognosis Factors of Neurological Evolution After Resuscitated Cardiac Arrest in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Régional Metz-Thionville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Régional Metz-Thionville</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>
      Sudden cardiac arrest (CA) in adults remains a major public health issue in industrialized&#xD;
      countries, leading to a mortality rate greater than 90%. The analysis of French data&#xD;
      estimates the number of sudden deaths at around 40,000 per year. The incidence rate for&#xD;
      non-hospital CAs is 55 per 100,000 every year with an immediate survival rate of 9% and 4.8%&#xD;
      at one year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 80 % of patients who survive CA with cardiopulmonary resuscitation are&#xD;
      comatose. The longer it lasts, the lower chances of recovery. The evaluation of the&#xD;
      neurological prognosis of these patients is an important issue. Indeed, 72% of patients&#xD;
      admitted to an intensive care unit after resuscitation from CA will give rise to an ethical&#xD;
      discussion with the family. The prognostication strategy is usually based on a multimodal&#xD;
      process involving clinical examination, electro-neurophysiological and biological&#xD;
      examinations. We plan to study the relevance of early neurological prognostic tests in the&#xD;
      aftermath of CA and in particular the most recent techniques such as the use of a clinical&#xD;
      score (CAHP for Cardiac Arrest Hospital Prognosis), automated infrared pupillometry&#xD;
      (NEUROLIGHT ALGISCAN, IDMED) for pupillary reflex measurement and quantitative analysis of&#xD;
      the continuous amplitude-integrated electroencephalogram (aEEG) BRAIN QUICK ICU LINE,&#xD;
      MICROMED. These new prognostic criteria for CA (CAHP score, pupillometry and aEEG) developed&#xD;
      separately have not yet been integrated into a multimodal strategy.&#xD;
&#xD;
      The goal of this study is to evaluate the performance of CAHP score, infrared automated&#xD;
      pupillometry and aEEG to predict as early as 24h from ROSC the neurological prognosis&#xD;
      (Cerebral Performance Categories) at hospital discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">September 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Cerebral Performance Categories (CPC) score</measure>
    <time_frame>Day 1</time_frame>
    <description>The Cerebral Performance Categories (CPC) score is evaluated by a physician at hospital discharge (CPC baseline assessed on basal statut before CA). Good neurological outcome defined as CPC &lt;3. CPC 1: no or minor disability (conscious and independent, able to work and lead a normal life. May have mild dysphasia, non-incapacitating hemiparesis, or minor cranial nerve abnormalities). CPC 2: Moderate disability (Conscious and independent, able to travel by public transport and work in sheltered environment, independent in activities of daily life. May have hemiplegia, seizures, ataxia, dysarthria or memory changes). Poor neurological outcome defined as CPC 3-5. CPC 3: severe disability (conscious but dependent, limited cognition, dementia, locked-in, minimally conscious. Usually in institution, but sometimes looked after at home with exceptional family effort). CPC 4: unconscious (persistent vegetative state). CPC 5: dead (certified brain dead or traditional criteria).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiac Arrest Hospital Prognosis (CAHP) Score</measure>
    <time_frame>Day 1</time_frame>
    <description>Seven variables independently associated with poor neurological outcome (age, non-shockable rythm, time from collapse to basic life support, time from basic life support to return of spontaneous circulation, location of cardiac arrest, epinephrine dose and arterial pH)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pupillary light reflex surveillance with automated infrared pupillometry</measure>
    <time_frame>Day 1</time_frame>
    <description>Bilateral testing by trained nurse (3 measures, best result between the 2 eyes considered)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuron Specific Enolase (NSE) plasmatic levels</measure>
    <time_frame>Day 2</time_frame>
    <description>Neuron Specific Enolase (NSE) plasmatic levels (ng/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuron Specific Enolase (NSE) plasmatic levels</measure>
    <time_frame>Day 3</time_frame>
    <description>Neuron Specific Enolase (NSE) plasmatic levels (ng/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amplitude-integrated electroencephalography (aEEG)</measure>
    <time_frame>Day 1</time_frame>
    <description>Amplitude-integrated electroencephalography (aEEG) with Hellstrom-Westas classification</description>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Cardiac Arrest</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Every major patient admitted in the Mercy Hospital CHR Metz-Thionville intensive care unit&#xD;
        after CA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admission in Intensive Care Unit (ICU) following cardiac arrest with ROSC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor patient&#xD;
&#xD;
          -  Cardiac arrest (CA) occuring in ICU&#xD;
&#xD;
          -  Decision before ICU admission to withdraw life-sustaining treatments&#xD;
&#xD;
          -  Patient with post-ROSC Glasgow Coma Score = 15&#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_contact>
    <last_name>Rostane GACI, MD</last_name>
    <phone>387186220</phone>
    <phone_ext>0033</phone_ext>
    <email>r.gaci@chr-metz-thionville.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Serge Le Tacon, MD</last_name>
    <phone>387186235</phone>
    <phone_ext>0033</phone_ext>
    <email>s.le-tacon@chr-metz-thionville.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHR Metz Thionville</name>
      <address>
        <city>Metz</city>
        <zip>57085</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nadia Ouamara</last_name>
      <phone>387557752</phone>
      <phone_ext>0033</phone_ext>
      <email>projet-recherche@chr-metz-thionville.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac Arrest</keyword>
  <keyword>Coma</keyword>
  <keyword>hypoxic brain damage</keyword>
  <keyword>prognosis</keyword>
  <keyword>neurological examination</keyword>
  <keyword>pupillary reflex</keyword>
  <keyword>electroencephalography</keyword>
  <keyword>targeted temperature management</keyword>
  <keyword>biomarkers</keyword>
  <keyword>clinical score</keyword>
  <keyword>evoked potentials</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
  </condition_browse>
  <!-- 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/NCT03806660
org study id: 2018-06Obs-CHRMT
nct id: NCT03806660
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sudden cardiac arrest (CA) in adults remains a major public health issue in industrialized
      countries, leading to a mortality rate greater than 90%. The analysis of French data
      estimates the number of sudden deaths at around 40,000 per year. The incidence rate for
      non-hospital CAs is 55 per 100,000 every year with an immediate survival rate of 9% and 4.8%
      at one year.
Approximately 80 % of patients who survive CA with cardiopulmonary resuscitation are
      comatose. The longer it lasts, the lower chances of recovery. The evaluation of the
      neurological prognosis of these patients is an important issue. Indeed, 72% of patients
      admitted to an intensive care unit after resuscitation from CA will give rise to an ethical
      discussion with the family. The prognostication strategy is usually based on a multimodal
      process involving clinical examination, electro-neurophysiological and biological
      examinations. We plan to study the relevance of early neurological prognostic tests in the
      aftermath of CA and in particular the most recent techniques such as the use of a clinical
      score (CAHP for Cardiac Arrest Hospital Prognosis), automated infrared pupillometry
      (NEUROLIGHT ALGISCAN, IDMED) for pupillary reflex measurement and quantitative analysis of
      the continuous amplitude-integrated electroencephalogram (aEEG) BRAIN QUICK ICU LINE,
      MICROMED. These new prognostic criteria for CA (CAHP score, pupillometry and aEEG) developed
      separately have not yet been integrated into a multimodal strategy.

      The goal of this study is to evaluate the performance of CAHP score, infrared automated
      pupillometry and aEEG to predict as early as 24h from ROSC the neurological prognosis
      (Cerebral Performance Categories) at hospital discharge.
observational model: Cohort
time perspective: Prospective
measure: Cerebral Performance Categories (CPC) score
time frame: Day 1
description: The Cerebral Performance Categories (CPC) score is evaluated by a physician at hospital discharge (CPC baseline assessed on basal statut before CA). Good neurological outcome defined as CPC <3. CPC 1: no or minor disability (conscious and independent, able to work and lead a normal life. May have mild dysphasia, non-incapacitating hemiparesis, or minor cranial nerve abnormalities). CPC 2: Moderate disability (Conscious and independent, able to travel by public transport and work in sheltered environment, independent in activities of daily life. May have hemiplegia, seizures, ataxia, dysarthria or memory changes). Poor neurological outcome defined as CPC 3-5. CPC 3: severe disability (conscious but dependent, limited cognition, dementia, locked-in, minimally conscious. Usually in institution, but sometimes looked after at home with exceptional family effort). CPC 4: unconscious (persistent vegetative state). CPC 5: dead (certified brain dead or traditional criteria).
measure: Cardiac Arrest Hospital Prognosis (CAHP) Score
time frame: Day 1
description: Seven variables independently associated with poor neurological outcome (age, non-shockable rythm, time from collapse to basic life support, time from basic life support to return of spontaneous circulation, location of cardiac arrest, epinephrine dose and arterial pH)
measure: Pupillary light reflex surveillance with automated infrared pupillometry
time frame: Day 1
description: Bilateral testing by trained nurse (3 measures, best result between the 2 eyes considered)
measure: Neuron Specific Enolase (NSE) plasmatic levels
time frame: Day 2
description: Neuron Specific Enolase (NSE) plasmatic levels (ng/ml)
measure: Neuron Specific Enolase (NSE) plasmatic levels
time frame: Day 3
description: Neuron Specific Enolase (NSE) plasmatic levels (ng/ml)
measure: Amplitude-integrated electroencephalography (aEEG)
time frame: Day 1
description: Amplitude-integrated electroencephalography (aEEG) with Hellstrom-Westas classification
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rostane GACI, MD
phone: 387186220
phone ext: 0033
email: r.gaci@chr-metz-thionville.fr
last name: Serge Le Tacon, MD
phone: 387186235
phone ext: 0033
email: s.le-tacon@chr-metz-thionville.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Heart Arrest