<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/NCT04490317</url>
  </required_header>
  <id_info>
    <org_study_id>CARE CO cohort</org_study_id>
    <nct_id>NCT04490317</nct_id>
  </id_info>
  <brief_title>CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)</brief_title>
  <official_title>CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wonju Severance Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wonju Severance Christian 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>
      This prospective cohort study enrolls subjects who experience carbon monoxide (CO) poisoning.&#xD;
      The purpose of the study is to evaluate therapeutic effects of various treatments and short&#xD;
      and long-term outcomes in CO poisoned patients. In addition, complications of brain and heart&#xD;
      susceptible to CO are investigated through various ways and the association between&#xD;
      complications and the patient's prognosis is also investigated. All subjects will be&#xD;
      regularly monitored by physicians participating in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective cohort study enrolls subjects who experience CO poisoning. The purpose of&#xD;
      the study is to evaluate therapeutic effects of various treatments, including hyperbaric&#xD;
      oxygen therapy (HBO), therapeutic hypothermia (TH), and additional drugs, and short and&#xD;
      long-term outcomes, such as neurocognitive sequelae or mortality, in CO poisoned patients. In&#xD;
      addition, complications of brain and heart susceptible to CO are investigated through a&#xD;
      variety of ways, such as magnetic resonance image (MRI), computed tomography (CT),&#xD;
      ultrasound, and laboratory test, and the association between various complications and the&#xD;
      patient's prognosis is also investigated. All subjects will be regularly monitored by&#xD;
      physicians participating in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 29, 2020</start_date>
  <completion_date type="Anticipated">December 2035</completion_date>
  <primary_completion_date type="Anticipated">December 2030</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>Therapeutic response to HBO at 1 month</measure>
    <time_frame>At 1 month after CO exposure</time_frame>
    <description>Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 1 month after CO exposure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Therapeutic response to HBO at 6 months</measure>
    <time_frame>At 6 months after CO exposure</time_frame>
    <description>Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 6 months after CO exposure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as neurocognitive function tests</measure>
    <time_frame>Within 1 month after CO exposure</time_frame>
    <description>Predictors and model development for poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by tools, such as global deterioration scale (GDS) or Carbon Monoxide Neuropsychological Screening Battery (CONSB), etc, through variables, such as clinical features, laboratory tests, or imaging study that can be investigated within 1 month</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by such as neurocognitive function tests</measure>
    <time_frame>Within 1 month after CO exposure</time_frame>
    <description>Predictors and model development for poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by tools, such as global deterioration scale (GDS) or Carbon Monoxide Neuropsychological Screening Battery (CONSB), etc, through variables, such as clinical features, laboratory tests, or imaging study that can be investigated within 1 month</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by such as neurocognitive function tests</measure>
    <time_frame>Within 1 month after CO exposure</time_frame>
    <description>Predictors and model development for poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by tools, such as global deterioration scale (GDS) or Carbon Monoxide Neuropsychological Screening Battery (CONSB), etc, through variables, such as clinical features, laboratory tests, or imaging study that can be investigated within 1 month</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Therapeutic response to HBO at 12 months</measure>
    <time_frame>At 12 months after CO exposure</time_frame>
    <description>Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 12 months after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic response to TH combined with HBO at 1 month</measure>
    <time_frame>At 1 month after CO exposure</time_frame>
    <description>Therapeutic response to TH combined with HBO in acute severe CO poisoning at 1 month after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic response to TH combined with HBO at 6 months</measure>
    <time_frame>At 6 months after CO exposure</time_frame>
    <description>Therapeutic response to TH combined with HBO in acute severe CO poisoning at 6 months after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic response to TH combined with HBO at 12 months</measure>
    <time_frame>At 12 months after CO exposure</time_frame>
    <description>Therapeutic response to TH combined with HBO in acute severe CO poisoning at 12 months after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic response to HBO according to presence of apolipoprotein E4 at 1 month</measure>
    <time_frame>At 1 month after CO exposure</time_frame>
    <description>Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 1 month after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic response to HBO according to presence of apolipoprotein E4 at 6 months</measure>
    <time_frame>At 6 months after CO exposure</time_frame>
    <description>Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 6 months after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic response to HBO according to presence of apolipoprotein E4 at 12 months after CO exposure</measure>
    <time_frame>At 12 months after CO exposure</time_frame>
    <description>Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 12 months after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac injury evaluated by cardiac MRI in acute phase</measure>
    <time_frame>Within 1 month after CO exposure</time_frame>
    <description>Cardiac injury related to CO poisoning evaluated by cardiac MRI in acute phase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac injury evaluated by cardiac MRI in chronic phase</measure>
    <time_frame>Follow-up cardiac MRI (at 4-8 months after CO exposure)</time_frame>
    <description>Cardiac injury related to CO poisoning evaluated by cardiac MRI in chronic phase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac injury evaluated by cardiac CT</measure>
    <time_frame>Within 1 month after CO exposure</time_frame>
    <description>Cardiac injury evaluated by cardiac CT in CO poisoning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac injury evaluated by TTE in acute phase</measure>
    <time_frame>Within 14 days after CO exposure</time_frame>
    <description>Cardiac injury related to CO poisoning evaluated by TTE in acute phase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac injury evaluated by TTE in chronic phase</measure>
    <time_frame>Within 4-8 months after CO exposure</time_frame>
    <description>Cardiac injury related to CO poisoning evaluated by TTE in chronic phase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain injury evaluated by brain imaging modality related to CO poisoning</measure>
    <time_frame>Within 6 months after CO exposure</time_frame>
    <description>Brain injury evaluated by brain MRI in CO poisoning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain injury related to CO poisoning</measure>
    <time_frame>Within 6 months after CO exposure</time_frame>
    <description>Brain injury evaluated by laboratory tests in CO poisoning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure</measure>
    <time_frame>Outcomes at 1 month after CO exposure</time_frame>
    <description>Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure</measure>
    <time_frame>Outcomes at 6 months after CO exposure</time_frame>
    <description>Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure</measure>
    <time_frame>Outcomes at 12 months after CO exposure</time_frame>
    <description>Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure</measure>
    <time_frame>Outcomes at 5 years after CO exposure</time_frame>
    <description>Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by neurocognitive function tests</measure>
    <time_frame>Outcomes at 1 month after CO exposure</time_frame>
    <description>Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as GDS or CONSB, etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by neurocognitive function tests</measure>
    <time_frame>Outcomes at 6 months after CO exposure</time_frame>
    <description>Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by such as GDS or CONSB, etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by neurocognitive function tests</measure>
    <time_frame>Outcomes at 12 months after CO exposure</time_frame>
    <description>Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by such as GDS or CONSB, etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by neurocognitive function tests</measure>
    <time_frame>Outcomes at 5 years after CO exposure</time_frame>
    <description>Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by such as GDS or CONSB, etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by neurocognitive function tests</measure>
    <time_frame>Outcomes at 1 month after CO exposure</time_frame>
    <description>Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as GDS or CONSB, etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by neurocognitive function tests</measure>
    <time_frame>Outcomes at 6 months after CO exposure</time_frame>
    <description>Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by such as GDS or CONSB, etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by neurocognitive function tests</measure>
    <time_frame>Outcomes at 12 months after CO exposure</time_frame>
    <description>Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by such as GDS or CONSB, etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by neurocognitive function tests</measure>
    <time_frame>Outcomes at 5 years after CO exposure</time_frame>
    <description>Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by such as GDS or CONSB, etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic response to drugs at 1 month</measure>
    <time_frame>At 1 month after CO exposure</time_frame>
    <description>Therapeutic response to additional drug including steroid at 1 month after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic response to drugs at 6 months</measure>
    <time_frame>At 6 months after CO exposure</time_frame>
    <description>Therapeutic response to additional drug including steroid at 6 months after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic response to drugs at 12 months</measure>
    <time_frame>At 12 months after CO exposure</time_frame>
    <description>Therapeutic response to additional drug including steroid at 12 months after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 1 month</measure>
    <time_frame>At 1 month after CO exposure</time_frame>
    <description>Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 1 month after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 6 months</measure>
    <time_frame>At 6 months after CO exposure</time_frame>
    <description>Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 6 months after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 12 months</measure>
    <time_frame>At 12 months after CO exposure</time_frame>
    <description>Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 12 months after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 5 years</measure>
    <time_frame>At 5 years after CO exposure</time_frame>
    <description>Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 5 years after CO exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organ injury related to CO poisoning</measure>
    <time_frame>Within 6 months after CO exposure</time_frame>
    <description>Organ injury, such as lung, kidney, liver, pancreas, or bowel, etc, related to CO poisoning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications related to CO poisoning</measure>
    <time_frame>Within 6 months after CO exposure</time_frame>
    <description>Complications, such as pulmonary thromboembolism or rhabdomyolysis, etc, related to CO poisoning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of HBO for delayed neurocognitive and psychological dysfunction at 1 year after onset</measure>
    <time_frame>Within 1 year after delayed neurocognitive and psychological sequelae onset</time_frame>
    <description>Effect of HBO for patient with delayed neurocognitive and psychological sequelae at 1 year after sequelae onset</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of HBO for delayed neurocognitive and psychological dysfunction at 2 years after onset</measure>
    <time_frame>Within 2 years after delayed neurocognitive and psychological sequelae onset</time_frame>
    <description>Effect of HBO for patient with delayed neurocognitive and psychological sequelae at 2 years after sequelae onset</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Validation of methods evaluating neurocognitive and psychological outcomes</measure>
    <time_frame>Within 6 months after CO exposure</time_frame>
    <description>Validation of methods evaluating neurocognitive and psychological outcomes within 6 months</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Carbon Monoxide Poisoning</condition>
  <condition>Myocardial Injury</condition>
  <condition>Neurologic Deficits</condition>
  <condition>Image, Body</condition>
  <condition>Therapy</condition>
  <condition>Prognostic Factors</condition>
  <condition>Complications</condition>
  <arm_group>
    <arm_group_label>Acute CO poisoning</arm_group_label>
    <description>A diagnosis of CO poisoning is made according to medical history and carboxyhemoglobin &gt;5% (&gt;10% in smokers).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cardiac MRI</intervention_name>
    <description>Cardiac MRI be taken to CO poisoned patients&#xD;
Cardiac CT be taken to CO poisoned patients&#xD;
TTE be taken to CO poisoned patients&#xD;
Brain MRI be taken to CO poisoned patients&#xD;
Neurocognitive function tests be taken to CO poisoned patients&#xD;
Laboratory tests be taken to CO poisoned patients</description>
    <arm_group_label>Acute CO poisoning</arm_group_label>
    <other_name>Cardiac CT</other_name>
    <other_name>Transthoracic echocardiography (TTE)</other_name>
    <other_name>Brain MRI</other_name>
    <other_name>Neurocognitive function tests</other_name>
    <other_name>Laboratory tests</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hyperbaric oxygen therapy</intervention_name>
    <description>Hyperbaric oxygen therapy be used for CO poisoned patients&#xD;
Therapeutic hypothermia be used for CO poisoned patients</description>
    <arm_group_label>Acute CO poisoning</arm_group_label>
    <other_name>Therapeutic hypothermia</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Acute CO poisoning&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute CO poisoning&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Declined to enrollment in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yong Sung Cha, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wonju Severance Christian Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yong Sung Cha, MD</last_name>
    <phone>+82-33-741-1615</phone>
    <email>emyscha@yonsei.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wonju Severance Christian Hospital</name>
      <address>
        <city>Wonju</city>
        <state>Gangwon</state>
        <zip>26426</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yong Sung Cha, MD</last_name>
      <phone>+82-33-741-1615</phone>
      <email>emyscha@yonsei.ac.kr</email>
    </contact>
    <investigator>
      <last_name>Yong Sung Cha, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>May 1, 2023</last_update_submitted>
  <last_update_submitted_qc>May 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wonju Severance Christian Hospital</investigator_affiliation>
    <investigator_full_name>Yong Sung Cha</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurologic Manifestations</mesh_term>
    <mesh_term>Poisoning</mesh_term>
    <mesh_term>Carbon Monoxide Poisoning</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/NCT04490317
org study id: CARE CO cohort
nct id: NCT04490317
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This prospective cohort study enrolls subjects who experience carbon monoxide (CO) poisoning.
      The purpose of the study is to evaluate therapeutic effects of various treatments and short
      and long-term outcomes in CO poisoned patients. In addition, complications of brain and heart
      susceptible to CO are investigated through various ways and the association between
      complications and the patient's prognosis is also investigated. All subjects will be
      regularly monitored by physicians participating in this study.
This prospective cohort study enrolls subjects who experience CO poisoning. The purpose of
      the study is to evaluate therapeutic effects of various treatments, including hyperbaric
      oxygen therapy (HBO), therapeutic hypothermia (TH), and additional drugs, and short and
      long-term outcomes, such as neurocognitive sequelae or mortality, in CO poisoned patients. In
      addition, complications of brain and heart susceptible to CO are investigated through a
      variety of ways, such as magnetic resonance image (MRI), computed tomography (CT),
      ultrasound, and laboratory test, and the association between various complications and the
      patient's prognosis is also investigated. All subjects will be regularly monitored by
      physicians participating in this study.
observational model: Cohort
time perspective: Prospective
measure: Therapeutic response to HBO at 1 month
time frame: At 1 month after CO exposure
description: Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 1 month after CO exposure
measure: Therapeutic response to HBO at 6 months
time frame: At 6 months after CO exposure
description: Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 6 months after CO exposure
measure: Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as neurocognitive function tests
time frame: Within 1 month after CO exposure
description: Predictors and model development for poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by tools, such as global deterioration scale (GDS) or Carbon Monoxide Neuropsychological Screening Battery (CONSB), etc, through variables, such as clinical features, laboratory tests, or imaging study that can be investigated within 1 month
measure: Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by such as neurocognitive function tests
time frame: Within 1 month after CO exposure
description: Predictors and model development for poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by tools, such as global deterioration scale (GDS) or Carbon Monoxide Neuropsychological Screening Battery (CONSB), etc, through variables, such as clinical features, laboratory tests, or imaging study that can be investigated within 1 month
measure: Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by such as neurocognitive function tests
time frame: Within 1 month after CO exposure
description: Predictors and model development for poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by tools, such as global deterioration scale (GDS) or Carbon Monoxide Neuropsychological Screening Battery (CONSB), etc, through variables, such as clinical features, laboratory tests, or imaging study that can be investigated within 1 month
measure: Therapeutic response to HBO at 12 months
time frame: At 12 months after CO exposure
description: Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 12 months after CO exposure
measure: Therapeutic response to TH combined with HBO at 1 month
time frame: At 1 month after CO exposure
description: Therapeutic response to TH combined with HBO in acute severe CO poisoning at 1 month after CO exposure
measure: Therapeutic response to TH combined with HBO at 6 months
time frame: At 6 months after CO exposure
description: Therapeutic response to TH combined with HBO in acute severe CO poisoning at 6 months after CO exposure
measure: Therapeutic response to TH combined with HBO at 12 months
time frame: At 12 months after CO exposure
description: Therapeutic response to TH combined with HBO in acute severe CO poisoning at 12 months after CO exposure
measure: Therapeutic response to HBO according to presence of apolipoprotein E4 at 1 month
time frame: At 1 month after CO exposure
description: Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 1 month after CO exposure
measure: Therapeutic response to HBO according to presence of apolipoprotein E4 at 6 months
time frame: At 6 months after CO exposure
description: Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 6 months after CO exposure
measure: Therapeutic response to HBO according to presence of apolipoprotein E4 at 12 months after CO exposure
time frame: At 12 months after CO exposure
description: Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 12 months after CO exposure
measure: Cardiac injury evaluated by cardiac MRI in acute phase
time frame: Within 1 month after CO exposure
description: Cardiac injury related to CO poisoning evaluated by cardiac MRI in acute phase
measure: Cardiac injury evaluated by cardiac MRI in chronic phase
time frame: Follow-up cardiac MRI (at 4-8 months after CO exposure)
description: Cardiac injury related to CO poisoning evaluated by cardiac MRI in chronic phase
measure: Cardiac injury evaluated by cardiac CT
time frame: Within 1 month after CO exposure
description: Cardiac injury evaluated by cardiac CT in CO poisoning
measure: Cardiac injury evaluated by TTE in acute phase
time frame: Within 14 days after CO exposure
description: Cardiac injury related to CO poisoning evaluated by TTE in acute phase
measure: Cardiac injury evaluated by TTE in chronic phase
time frame: Within 4-8 months after CO exposure
description: Cardiac injury related to CO poisoning evaluated by TTE in chronic phase
measure: Brain injury evaluated by brain imaging modality related to CO poisoning
time frame: Within 6 months after CO exposure
description: Brain injury evaluated by brain MRI in CO poisoning
measure: Brain injury related to CO poisoning
time frame: Within 6 months after CO exposure
description: Brain injury evaluated by laboratory tests in CO poisoning
measure: Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure
time frame: Outcomes at 1 month after CO exposure
description: Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure
measure: Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure
time frame: Outcomes at 6 months after CO exposure
description: Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure
measure: Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure
time frame: Outcomes at 12 months after CO exposure
description: Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure
measure: Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure
time frame: Outcomes at 5 years after CO exposure
description: Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure
measure: Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by neurocognitive function tests
time frame: Outcomes at 1 month after CO exposure
description: Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as GDS or CONSB, etc
measure: Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by neurocognitive function tests
time frame: Outcomes at 6 months after CO exposure
description: Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by such as GDS or CONSB, etc
measure: Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by neurocognitive function tests
time frame: Outcomes at 12 months after CO exposure
description: Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by such as GDS or CONSB, etc
measure: Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by neurocognitive function tests
time frame: Outcomes at 5 years after CO exposure
description: Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by such as GDS or CONSB, etc
measure: Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by neurocognitive function tests
time frame: Outcomes at 1 month after CO exposure
description: Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as GDS or CONSB, etc
measure: Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by neurocognitive function tests
time frame: Outcomes at 6 months after CO exposure
description: Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by such as GDS or CONSB, etc
measure: Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by neurocognitive function tests
time frame: Outcomes at 12 months after CO exposure
description: Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by such as GDS or CONSB, etc
measure: Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by neurocognitive function tests
time frame: Outcomes at 5 years after CO exposure
description: Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by such as GDS or CONSB, etc
measure: Therapeutic response to drugs at 1 month
time frame: At 1 month after CO exposure
description: Therapeutic response to additional drug including steroid at 1 month after CO exposure
measure: Therapeutic response to drugs at 6 months
time frame: At 6 months after CO exposure
description: Therapeutic response to additional drug including steroid at 6 months after CO exposure
measure: Therapeutic response to drugs at 12 months
time frame: At 12 months after CO exposure
description: Therapeutic response to additional drug including steroid at 12 months after CO exposure
measure: Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 1 month
time frame: At 1 month after CO exposure
description: Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 1 month after CO exposure
measure: Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 6 months
time frame: At 6 months after CO exposure
description: Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 6 months after CO exposure
measure: Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 12 months
time frame: At 12 months after CO exposure
description: Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 12 months after CO exposure
measure: Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 5 years
time frame: At 5 years after CO exposure
description: Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 5 years after CO exposure
measure: Organ injury related to CO poisoning
time frame: Within 6 months after CO exposure
description: Organ injury, such as lung, kidney, liver, pancreas, or bowel, etc, related to CO poisoning
measure: Complications related to CO poisoning
time frame: Within 6 months after CO exposure
description: Complications, such as pulmonary thromboembolism or rhabdomyolysis, etc, related to CO poisoning
measure: Effect of HBO for delayed neurocognitive and psychological dysfunction at 1 year after onset
time frame: Within 1 year after delayed neurocognitive and psychological sequelae onset
description: Effect of HBO for patient with delayed neurocognitive and psychological sequelae at 1 year after sequelae onset
measure: Effect of HBO for delayed neurocognitive and psychological dysfunction at 2 years after onset
time frame: Within 2 years after delayed neurocognitive and psychological sequelae onset
description: Effect of HBO for patient with delayed neurocognitive and psychological sequelae at 2 years after sequelae onset
measure: Validation of methods evaluating neurocognitive and psychological outcomes
time frame: Within 6 months after CO exposure
description: Validation of methods evaluating neurocognitive and psychological outcomes within 6 months
arm group label: Acute CO poisoning
description: A diagnosis of CO poisoning is made according to medical history and carboxyhemoglobin >5% (>10% in smokers).
intervention type: Diagnostic Test
intervention name: Cardiac MRI
description: Cardiac MRI be taken to CO poisoned patients
Cardiac CT be taken to CO poisoned patients
TTE be taken to CO poisoned patients
Brain MRI be taken to CO poisoned patients
Neurocognitive function tests be taken to CO poisoned patients
Laboratory tests be taken to CO poisoned patients
arm group label: Acute CO poisoning
other name: Cardiac CT
other name: Transthoracic echocardiography (TTE)
other name: Brain MRI
other name: Neurocognitive function tests
other name: Laboratory tests
intervention type: Procedure
intervention name: Hyperbaric oxygen therapy
description: Hyperbaric oxygen therapy be used for CO poisoned patients
Therapeutic hypothermia be used for CO poisoned patients
arm group label: Acute CO poisoning
other name: Therapeutic hypothermia
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yong Sung Cha, MD
role: Principal Investigator
affiliation: Wonju Severance Christian Hospital
last name: Yong Sung Cha, MD
phone: +82-33-741-1615
email: emyscha@yonsei.ac.kr
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Wonju Severance Christian Hospital
investigator full name: Yong Sung Cha
investigator title: Assistant Professor
mesh term: Neurologic Manifestations
mesh term: Poisoning
mesh term: Carbon Monoxide Poisoning