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/NCT05965362</url>
    </required_header>
    <id_info>
      <org_study_id>XJTU1AF2023LSK-151</org_study_id>
      <nct_id>NCT05965362</nct_id>
    </id_info>
    <brief_title>Prognosis of Patients With Infective Endocarditis and Risk Stratification Value of Biomarkers (ENDEAVOR）</brief_title>
    <acronym>ENDEAVOR</acronym>
    <official_title>Prognosis of Patients With Infective Endocarditis and Risk Stratification Value of Biomarkers (ENDEAVOR): a National Multi-center, Retrospective-prospective, Cohort Study Initiated by the Investigators</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>521 Hospital of NORINCO Group</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shaanxi Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xiangyang Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Henan Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>First Affiliated Hospital Xi'an Jiaotong University</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>
        In this study, by establishing a clinical cohort of infective endocarditis, we observed the&#xD;
        natural prognosis and influencing factors in the process of disease development and&#xD;
        regression; we used multi-omics technology to understand the prognostic value of its&#xD;
        biomarkers, and provided new ideas and evidence for the pathogenesis, clinical diagnosis and&#xD;
        treatment of IE.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Infective endocarditis is an inflammation of the inner lining of the heart valves or&#xD;
        ventricular walls caused by direct infection of the heart by bacteria, fungi and other&#xD;
        microorganisms via the bloodstream route. At present, the clinical diagnosis of IE is mainly&#xD;
        based on a combination of typical symptoms, imaging and blood culture, etc. Finding more&#xD;
        sensitive means and more accurate indicators for early detection of IE flora distribution&#xD;
        characteristics is of great significance for the prevention and targeted treatment of IE.&#xD;
        Therefore, in this study, by establishing a clinical cohort of infective endocarditis, we&#xD;
        observed the natural prognosis and influencing factors in the process of disease development&#xD;
        and regression; we used multi-omics technology to understand the prognostic value of its&#xD;
        biomarkers, and provided new ideas and evidence for the pathogenesis, clinical diagnosis and&#xD;
        treatment of IE.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 31, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2028</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>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in the incidence of MACCE</measure>
      <time_frame>1, 3, 6 months and 1, 2, 3, 5 years after enrollment.</time_frame>
      <description>MACCE is major adverse cardio-cerebrovascular events, including myocardial infarction, stroke, vessel revascularization and all-cause death. The MACCE will be assessed from the medical records.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse thrombus complications</measure>
      <time_frame>5 years after the enrollment.</time_frame>
      <description>Adverse thrombus complications including systemic embolism, infected aneurysm, splenic abscess, etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the incidence of infection recurrence</measure>
      <time_frame>1, 3, 6 months and 1, 2, 3, 5 years after enrollment.</time_frame>
      <description>Diagnosis of infective endocarditis by clinical guidelines, which will be assessed from medical records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the incidence of myocardial infarction</measure>
      <time_frame>1, 3, 6 months and 1, 2, 3, 5 years after enrollment.</time_frame>
      <description>Myocardial infarction, diagnosed by clinical doctors, will be assessed from medical records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the incidence of stroke</measure>
      <time_frame>1, 3, 6 months and 1, 2, 3, 5 years after enrollment.</time_frame>
      <description>Stroke, diagnosed by clinical doctors, will be assessed from medical records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the incidence of vessel revascularization</measure>
      <time_frame>1, 3, 6 months and 1, 2, 3, 5 years after enrollment.</time_frame>
      <description>Vessel revascularization, diagnosed by clinical doctors, will be assessed from medical records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the incidence of all-cause death</measure>
      <time_frame>1, 3, 6 months and 1, 2, 3, 5 years after enrollment.</time_frame>
      <description>All-cause death, diagnosed by clinical doctors, will be assessed from medical records.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Infective Endocarditis</condition>
    <arm_group>
      <arm_group_label>Infective endocarditis group</arm_group_label>
      <description>Patients diagnosed with infective endocarditis.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Observational; No Interventions were given.</intervention_name>
      <description>Observational; No Interventions were given.</description>
      <arm_group_label>Infective endocarditis group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood, feces, urine, valvular, superfluous organisms, adipose tissue and pericardial&#xD;
        effusion.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with clinically confirmed infective endocarditis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with clinically confirmed infective endocarditis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients refuse to sign informed consent form&#xD;
  &#xD;
            -  Patients who combined with serious systemic diseases, cannot tolerate the acquisition&#xD;
               of biological samples&#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_official>
      <last_name>Yang Yan</last_name>
      <role>Principal Investigator</role>
      <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Guoliang Li</last_name>
      <role>Principal Investigator</role>
      <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guoliang Li</last_name>
      <phone>+8613759982523</phone>
      <email>liguoliang_med@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yang Yan</last_name>
      <phone>+8613259882601</phone>
      <email>yangyan3@xjtu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>First Affiliated Hospital of Xian Jiantong University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710061</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Guoliang Li</last_name>
        <phone>008613759982523</phone>
        <email>liguoliang_med@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>February 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Infective Endocarditis</keyword>
    <keyword>Prognosis</keyword>
    <keyword>Major Adverse Cardiac and Cerebrovascular event</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Endocarditis, Bacterial</mesh_term>
      <mesh_term>Endocarditis</mesh_term>
    </condition_browse>
    <!-- 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/NCT05965362
  org study id: XJTU1AF2023LSK-151
  nct id: NCT05965362
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  In this study, by establishing a clinical cohort of infective endocarditis, we observed the
        natural prognosis and influencing factors in the process of disease development and
        regression; we used multi-omics technology to understand the prognostic value of its
        biomarkers, and provided new ideas and evidence for the pathogenesis, clinical diagnosis and
        treatment of IE.
  Infective endocarditis is an inflammation of the inner lining of the heart valves or
        ventricular walls caused by direct infection of the heart by bacteria, fungi and other
        microorganisms via the bloodstream route. At present, the clinical diagnosis of IE is mainly
        based on a combination of typical symptoms, imaging and blood culture, etc. Finding more
        sensitive means and more accurate indicators for early detection of IE flora distribution
        characteristics is of great significance for the prevention and targeted treatment of IE.
        Therefore, in this study, by establishing a clinical cohort of infective endocarditis, we
        observed the natural prognosis and influencing factors in the process of disease development
        and regression; we used multi-omics technology to understand the prognostic value of its
        biomarkers, and provided new ideas and evidence for the pathogenesis, clinical diagnosis and
        treatment of IE.
  observational model: Cohort
  time perspective: Other
  measure: Change in the incidence of MACCE
  time frame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
  description: MACCE is major adverse cardio-cerebrovascular events, including myocardial infarction, stroke, vessel revascularization and all-cause death. The MACCE will be assessed from the medical records.
  measure: Incidence of adverse thrombus complications
  time frame: 5 years after the enrollment.
  description: Adverse thrombus complications including systemic embolism, infected aneurysm, splenic abscess, etc.
  measure: Change in the incidence of infection recurrence
  time frame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
  description: Diagnosis of infective endocarditis by clinical guidelines, which will be assessed from medical records.
  measure: Change in the incidence of myocardial infarction
  time frame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
  description: Myocardial infarction, diagnosed by clinical doctors, will be assessed from medical records.
  measure: Change in the incidence of stroke
  time frame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
  description: Stroke, diagnosed by clinical doctors, will be assessed from medical records.
  measure: Change in the incidence of vessel revascularization
  time frame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
  description: Vessel revascularization, diagnosed by clinical doctors, will be assessed from medical records.
  measure: Change in the incidence of all-cause death
  time frame: 1, 3, 6 months and 1, 2, 3, 5 years after enrollment.
  description: All-cause death, diagnosed by clinical doctors, will be assessed from medical records.
  arm group label: Infective endocarditis group
  description: Patients diagnosed with infective endocarditis.
  intervention type: Other
  intervention name: Observational; No Interventions were given.
  description: Observational; No Interventions were given.
  arm group label: Infective endocarditis group
  Blood, feces, urine, valvular, superfluous organisms, adipose tissue and pericardial
        effusion.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yang Yan
  role: Principal Investigator
  affiliation: First Affiliated Hospital Xi'an Jiaotong University
  last name: Guoliang Li
  role: Principal Investigator
  affiliation: First Affiliated Hospital Xi'an Jiaotong University
  last name: Guoliang Li
  phone: +8613759982523
  email: liguoliang_med@163.com
  last name: Yang Yan
  phone: +8613259882601
  email: yangyan3@xjtu.edu.cn
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Endocarditis, Bacterial
  mesh term: Endocarditis