xml: <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/NCT06012994</url>
    </required_header>
    <id_info>
      <org_study_id>mzk202303</org_study_id>
      <nct_id>NCT06012994</nct_id>
    </id_info>
    <brief_title>Retrospective Study of the Protective Effect of Gastrodin on Myocardium in Patients Undergoing Cardiac Surgery</brief_title>
    <official_title>Retrospective Study of the Protective Effect of Gastrodin on Myocardium in Patients Undergoing Cardiac Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wuhan Union Hospital, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wuhan Union Hospital, China</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Retrospective collection of Wuhan Union hospital from December 1,2018 to June 30,2021 to meet&#xD;
        the entry and discharge standards. The patient 's medical record data were divided into study&#xD;
        group and control group according to the use of gastrodin during operation. The perioperative&#xD;
        data and prognostic outcomes in the patient 's medical records were collected and analyzed.&#xD;
        The degree of myocardial injury and postoperative clinical outcomes were compared between the&#xD;
        two groups.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2018</start_date>
    <completion_date type="Actual">July 31, 2023</completion_date>
    <primary_completion_date type="Actual">June 30, 2021</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The degree of myocardial injury</measure>
      <time_frame>The myocardial tissue was collected during the operation. About 2 hours on average</time_frame>
      <description>The myocardial tissue trimmed by the surgeon according to the surgical requirements was collected during the operation for electron microscopy observation and detection of related molecular content.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">160</enrollment>
    <condition>Cardiac Surgical Procedures</condition>
    <arm_group>
      <arm_group_label>GAS</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          This study included patients who were preoperatively diagnosed as requiring elective&#xD;
          thoracic cardiac surgery under general anesthesia.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged≥18 years, regardless of gender;&#xD;
  &#xD;
            -  Patients undergoing elective cardiac surgery under general anesthesia;&#xD;
  &#xD;
            -  ASA grade 1 ~ 3.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Suffering from more serious genetic diseases (such as immunodeficiency, thalassemia,&#xD;
               etc.);&#xD;
  &#xD;
            -  Moderate to severe malnutrition, moderate to severe anemia;&#xD;
  &#xD;
            -  Persistent infection;&#xD;
  &#xD;
            -  Severe preoperative underlying diseases (such as severe liver and kidney dysfunction)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430022</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012994
  org study id: mzk202303
  nct id: NCT06012994
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Retrospective collection of Wuhan Union hospital from December 1,2018 to June 30,2021 to meet
        the entry and discharge standards. The patient 's medical record data were divided into study
        group and control group according to the use of gastrodin during operation. The perioperative
        data and prognostic outcomes in the patient 's medical records were collected and analyzed.
        The degree of myocardial injury and postoperative clinical outcomes were compared between the
        two groups.
  observational model: Cohort
  time perspective: Retrospective
  measure: The degree of myocardial injury
  time frame: The myocardial tissue was collected during the operation. About 2 hours on average
  description: The myocardial tissue trimmed by the surgeon according to the surgical requirements was collected during the operation for electron microscopy observation and detection of related molecular content.
  arm group label: GAS
  arm group label: Control
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor