<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/NCT02206412</url>
  </required_header>
  <id_info>
    <org_study_id>4-2013-0341</org_study_id>
    <nct_id>NCT02206412</nct_id>
  </id_info>
  <brief_title>Role of High Mobility Group Box 1 as a Prognostic Biomarker in Patients Undergoing Off-pump Coronary Artery Bypass Graft</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      High mobility group 1 (HMGB1) protein is both a nuclear factor and a secreted protein, and&#xD;
      has recently been identified as a cytokine mediator of systemic inflammation. HMGB1 is&#xD;
      released by inflammatory cells actively, or increased during cell death passively and&#xD;
      mediates inflammatory response. It has been reported to have association with the prognosis&#xD;
      after acute coronary syndrome, ischemia-reperfusion injury of myocardium, atherosclerosis and&#xD;
      heart failure. This study aimed to investigate the relationship of serum levels of HMGB1 and&#xD;
      post operative prognosis of patients who had undergone off-pump coronary artery bypass graft.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 16, 2017</completion_date>
  <primary_completion_date type="Actual">March 16, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum value of HMGB1</measure>
    <time_frame>Change from induction of anesthesia to 2hrs after transfer to intensive care unit</time_frame>
    <description>Measure the maximum value of HMGB1 in all patients and calculate median value. And device into upper median value group and under median value group and compare frequency of composite morbidity/mortality rate between two groups. composite morbidity/mortality is as follows:&#xD;
Stroke&#xD;
Renal failure&#xD;
Prolonged ventilation more than 24 hours&#xD;
Deep sternal wound infection&#xD;
Reoperation for any reason&#xD;
Mortality during the hospitalization for surgery, even if over 30 days</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">255</enrollment>
  <condition>Coronary Artery Occlusive Disease</condition>
  <arm_group>
    <arm_group_label>HMGB1 group</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients over age 20 who are undergoing off-pump coronary artery bypass graft&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 20&#xD;
&#xD;
          2. Patients undergoing off-pump coronary artery bypass graft&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt; 20&#xD;
&#xD;
          2. Patients undergoing off-pump coronary artery bypass graft with other simultaneous&#xD;
             surgery&#xD;
&#xD;
          3. Patients participating other study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology &amp; Pain Medicine, Yonsei university college of medicine</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>June 20, 2018</last_update_submitted>
  <last_update_submitted_qc>June 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>high mobility group box 1</keyword>
  <keyword>prognostic biomarker</keyword>
  <keyword>off-pump coronary artery bypass graft</keyword>
  <keyword>patients</keyword>
  <!-- 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/NCT02206412
org study id: 4-2013-0341
nct id: NCT02206412
lead sponsor: 
has dmc: No
High mobility group 1 (HMGB1) protein is both a nuclear factor and a secreted protein, and
      has recently been identified as a cytokine mediator of systemic inflammation. HMGB1 is
      released by inflammatory cells actively, or increased during cell death passively and
      mediates inflammatory response. It has been reported to have association with the prognosis
      after acute coronary syndrome, ischemia-reperfusion injury of myocardium, atherosclerosis and
      heart failure. This study aimed to investigate the relationship of serum levels of HMGB1 and
      post operative prognosis of patients who had undergone off-pump coronary artery bypass graft.
observational model: Case-Only
time perspective: Prospective
measure: Maximum value of HMGB1
time frame: Change from induction of anesthesia to 2hrs after transfer to intensive care unit
description: Measure the maximum value of HMGB1 in all patients and calculate median value. And device into upper median value group and under median value group and compare frequency of composite morbidity/mortality rate between two groups. composite morbidity/mortality is as follows:
Stroke
Renal failure
Prolonged ventilation more than 24 hours
Deep sternal wound infection
Reoperation for any reason
Mortality during the hospitalization for surgery, even if over 30 days
arm group label: HMGB1 group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor