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/NCT06010199</url>
    </required_header>
    <id_info>
      <org_study_id>XJTU1AF2023LSK-169</org_study_id>
      <nct_id>NCT06010199</nct_id>
    </id_info>
    <brief_title>Risk Stratification Value of Biomarkers in Patients With Myocarditis</brief_title>
    <acronym>FORWARD</acronym>
    <official_title>Risk Stratification Value of Biomarkers in Patients With Myocarditis (FORWARD): a National, Multicenter, Retrospective-prospective, Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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>
        The aim of this study is to collect clinical data and biological specimens from patients with&#xD;
        myocarditis and construct a predictive model for the prognosis of myocarditis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this study is to retrospectively and prospectively collect clinical data and&#xD;
        biological specimens from patients with myocarditis who meet the inclusion and exclusion&#xD;
        criteria. General molecular biology analysis, genome sequencing, transcriptome sequencing,&#xD;
        methylation sequencing, metabolomics analysis, proteomics analysis, genome-wide chromosome&#xD;
        conformation capture and other techniques are used to construct a prognosis prediction model&#xD;
        for myocarditis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2030</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2030</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 MACE</measure>
      <time_frame>1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.</time_frame>
      <description>MACE (major adverse cardiovascular events) including all-cause death, myocardial infarction, stroke and coronary revascularization surgery. The MACE will be assessed from the medical records.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in the incidence of all-cause death</measure>
      <time_frame>1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.</time_frame>
      <description>All-cause death diagnosed by clinical doctors will be assessed from the medical records</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the incidence of myocardial infarction</measure>
      <time_frame>1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.</time_frame>
      <description>Myocardial infarction diagnosed by clinical doctors will be assessed from the medical records</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the incidence of stroke</measure>
      <time_frame>1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.</time_frame>
      <description>Stroke diagnosed by clinical doctors will be assessed from the medical records</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the incidence of coronary revascularization surgery</measure>
      <time_frame>1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.</time_frame>
      <description>Coronary revascularization surgery completed by clinical doctors will be assessed from the medical records</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Myocarditis</condition>
    <arm_group>
      <arm_group_label>Myocarditis group</arm_group_label>
      <description>All enrolled patients are administered antiviral drugs, glucocorticoids, immunoglobulins, and other standard treatments. Additionally, the decision to provide ECMO support therapy is based on the severity of the patient's condition.</description>
    </arm_group>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood, urine, feces.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          All hospitalized patients who meet the diagnostic criteria for myocarditis and undergo&#xD;
          regular follow-up at the corresponding cardiovascular center are included in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients should meet the diagnostic criteria for myocarditis&#xD;
  &#xD;
            -  Patients who are regularly followed up at the corresponding cardiovascular center&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;3 years or &gt;80 years&#xD;
  &#xD;
            -  Pregnant or lactating women&#xD;
  &#xD;
            -  The patient refused to sign the informed consent and refused to participate in the&#xD;
               study&#xD;
  &#xD;
            -  None of the above is consistent, but the patient cannot sign the informed consent&#xD;
               temporarily due to coma and other reasons, and there is no legal representative to&#xD;
               sign it instead. Depending on the condition, the patient may not wake up to sign the&#xD;
               informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>80 Years</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 Xi'an Jiaotong 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>13759982523</phone>
        <email>liguoliang_med@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Yang Yan</last_name>
        <phone>+862985323865</phone>
        <email>yangyan3@xjtu.edu.cn</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Myocarditis</keyword>
    <keyword>Biomarker</keyword>
    <keyword>Risk stratification</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myocarditis</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/NCT06010199
  org study id: XJTU1AF2023LSK-169
  nct id: NCT06010199
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to collect clinical data and biological specimens from patients with
        myocarditis and construct a predictive model for the prognosis of myocarditis.
  The aim of this study is to retrospectively and prospectively collect clinical data and
        biological specimens from patients with myocarditis who meet the inclusion and exclusion
        criteria. General molecular biology analysis, genome sequencing, transcriptome sequencing,
        methylation sequencing, metabolomics analysis, proteomics analysis, genome-wide chromosome
        conformation capture and other techniques are used to construct a prognosis prediction model
        for myocarditis.
  observational model: Cohort
  time perspective: Other
  measure: Change in the incidence of MACE
  time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
  description: MACE (major adverse cardiovascular events) including all-cause death, myocardial infarction, stroke and coronary revascularization surgery. The MACE will be assessed from the medical records.
  measure: Change in the incidence of all-cause death
  time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
  description: All-cause death diagnosed by clinical doctors will be assessed from the medical records
  measure: Change in the incidence of myocardial infarction
  time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
  description: Myocardial infarction diagnosed by clinical doctors will be assessed from the medical records
  measure: Change in the incidence of stroke
  time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
  description: Stroke diagnosed by clinical doctors will be assessed from the medical records
  measure: Change in the incidence of coronary revascularization surgery
  time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
  description: Coronary revascularization surgery completed by clinical doctors will be assessed from the medical records
  arm group label: Myocarditis group
  description: All enrolled patients are administered antiviral drugs, glucocorticoids, immunoglobulins, and other standard treatments. Additionally, the decision to provide ECMO support therapy is based on the severity of the patient's condition.
  Blood, urine, feces.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 80 Years
  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: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Myocarditis