<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/NCT04460131</url>
  </required_header>
  <id_info>
    <org_study_id>sST2-2019</org_study_id>
    <nct_id>NCT04460131</nct_id>
  </id_info>
  <brief_title>Soluble ST2 and Cardiovascular Outcome</brief_title>
  <official_title>Association Between Soluble ST2 and Cardiovascular Outcome After Cardiovascular Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Cardiac surgery induces hemodynamic stress on the myocardium, and this process can be&#xD;
      associated with significant cardiovascular morbidity and mortality. Soluble suppression of&#xD;
      tumorigenicity 2 (sST2) is biomarker of myocardial remodeling and fibrosis; however, little&#xD;
      is known regarding their potential association with cardiovascular events. This study aimed&#xD;
      to investigate the release of sST2 and its association with cardiovascular events undergoing&#xD;
      cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</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>All-cause mortality</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Number of participants death of 30 days after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart failure</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>requiring initiation or change in heart failure medication or requiring hospitalisation</description>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Cardiovascular Disease</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>soluble ST2</intervention_name>
    <description>Serum sST2 was measured on a monoclonal electrochemiluminescence immunoassay. Samples were exposed to two freeze cycles before analysed. Samples were exposed to two thawfreeze cycles before analysed.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive adults patients with heart disease who underwent cardiac surgery were included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18 years&#xD;
&#xD;
          -  Congenital heart disease requiring surgery&#xD;
&#xD;
          -  Valvular heart disease requiring surgery&#xD;
&#xD;
          -  Arrhythmia requiring surgery&#xD;
&#xD;
          -  Aortic dissection requiring surgery&#xD;
&#xD;
          -  Coronary heart disease requiring surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;18 years&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  severe renal dysfunction (creatinine &gt;200µmol/L)&#xD;
&#xD;
          -  not capable of understanding or signing informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Yong-feng Shao</last_name>
    <role>Study Chair</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yong-feng Shao</last_name>
    <phone>+8618801281613</phone>
    <email>yfshaojph@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hong Liu</last_name>
    <phone>+8618322341013</phone>
    <email>dr.hongliu@foxmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The first affiliated hospital of nanjing medical university</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Liu, MD</last_name>
      <phone>188012181613</phone>
      <email>dr.hongliu@foxmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>April 15, 2022</last_update_submitted>
  <last_update_submitted_qc>April 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Hong Liu</investigator_full_name>
    <investigator_title>Investigator of Nanjing Medical University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT04460131
org study id: sST2-2019
nct id: NCT04460131
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cardiac surgery induces hemodynamic stress on the myocardium, and this process can be
      associated with significant cardiovascular morbidity and mortality. Soluble suppression of
      tumorigenicity 2 (sST2) is biomarker of myocardial remodeling and fibrosis; however, little
      is known regarding their potential association with cardiovascular events. This study aimed
      to investigate the release of sST2 and its association with cardiovascular events undergoing
      cardiac surgery.
observational model: Cohort
time perspective: Prospective
measure: All-cause mortality
time frame: 30 days after surgery
description: Number of participants death of 30 days after surgery
measure: Heart failure
time frame: 30 days after surgery
description: requiring initiation or change in heart failure medication or requiring hospitalisation
intervention type: Diagnostic Test
intervention name: soluble ST2
description: Serum sST2 was measured on a monoclonal electrochemiluminescence immunoassay. Samples were exposed to two freeze cycles before analysed. Samples were exposed to two thawfreeze cycles before analysed.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
last name: Yong-feng Shao
role: Study Chair
affiliation: The First Affiliated Hospital with Nanjing Medical University
last name: Yong-feng Shao
phone: +8618801281613
email: yfshaojph@sina.com
last name: Hong Liu
phone: +8618322341013
email: dr.hongliu@foxmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanjing Medical University
investigator full name: Hong Liu
investigator title: Investigator of Nanjing Medical University
mesh term: Cardiovascular Diseases