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/NCT06012968</url>
    </required_header>
    <id_info>
      <org_study_id>mzk202301</org_study_id>
      <nct_id>NCT06012968</nct_id>
    </id_info>
    <brief_title>Study on the Protective Effect of Gastrodin on Myocardial Injury in Patients Undergoing Cardiac Surgery</brief_title>
    <official_title>Study on the Protective Effect of Gastrodin on Myocardial Injury 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>
        This study intends to include hypertrophic cardiomyopathy patients over 18 years old who&#xD;
        underwent cardiac surgery in our hospital. Patients were divided into medication group and&#xD;
        control group according to the use of gastrodin during operation. The patients ' myocardial&#xD;
        tissue samples were collected, the postoperative prognosis data were observed and recorded,&#xD;
        and the data were analyzed. The degree of myocardial tissue cell damage and postoperative&#xD;
        clinical outcomes were compared between the two groups.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</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>Degree of myocardial cell injury</measure>
      <time_frame>During postoperative hospitalization stay, an average of about two weeks</time_frame>
      <description>Postoperative myocardial injury marker serum concentration, postoperative cardiac function ultrasound index</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">10</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>
          The patients included in this study were preoperatively diagnosed as hypertrophic&#xD;
          cardiomyopathy.&#xD;
  &#xD;
          Diagnosis of hypertrophic cardiomyopathy: according to the medical history and physical&#xD;
          examination, echocardiography showed diastolic ventricular septal thickness of 15 mm.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with hypertrophic cardiomyopathy aged≥18 years, regardless of gender;&#xD;
  &#xD;
            -  Patients undergoing elective hypertrophic cardiomyopathy outflow tract surgery;&#xD;
  &#xD;
            -  Signed informed consent, good compliance.&#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>
    <overall_contact>
      <last_name>Qingping Wu, doctor</last_name>
      <phone>13971605283</phone>
      <email>wqp1968@126.com</email>
    </overall_contact>
    <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>
      <status>Recruiting</status>
      <contact>
        <last_name>Qingping Wu</last_name>
        <email>wqp1968@163.com</email>
      </contact>
    </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/NCT06012968
  org study id: mzk202301
  nct id: NCT06012968
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study intends to include hypertrophic cardiomyopathy patients over 18 years old who
        underwent cardiac surgery in our hospital. Patients were divided into medication group and
        control group according to the use of gastrodin during operation. The patients ' myocardial
        tissue samples were collected, the postoperative prognosis data were observed and recorded,
        and the data were analyzed. The degree of myocardial tissue cell damage and postoperative
        clinical outcomes were compared between the two groups.
  observational model: Cohort
  time perspective: Prospective
  measure: Degree of myocardial cell injury
  time frame: During postoperative hospitalization stay, an average of about two weeks
  description: Postoperative myocardial injury marker serum concentration, postoperative cardiac function ultrasound index
  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
  last name: Qingping Wu, doctor
  phone: 13971605283
  email: wqp1968@126.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor