<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/NCT03268642</url>
  </required_header>
  <id_info>
    <org_study_id>TJH-C20160202</org_study_id>
    <nct_id>NCT03268642</nct_id>
  </id_info>
  <brief_title>Clinical Assessment of New Treatment Regimen for Adult Fulminant Myocarditis</brief_title>
  <official_title>Assesment of Clinical Therapeutic Efficacy of &quot;Life-support Based Comprehensive Treatment Regimen&quot; for Adult Fulminant Myocarditis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji Hospital</source>
  <brief_summary>
    <textblock>
      This is a retrospective cohort study to assess the clinical outcome of patients with&#xD;
      fulminant myocarditis using &quot;Life-support Based Comprehensive Treatment Regimen&quot; and&#xD;
      conventional therapy. In the present study, participants receive various treatment as part of&#xD;
      routine medical care without any assignment of specific interventions to them. The process of&#xD;
      treatment during hospitalization were recorded in medical chart and was reviewed by&#xD;
      independent research personnel.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 1, 2016</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>death or cardiac transplantation</measure>
    <time_frame>through hospital discharge, an average of 10 days</time_frame>
    <description>The occurrence of death or cardiac transplantation was determined through direct contact with the patient or the family of the patient or review of the patient's medical record.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Fulminant Myocarditis</condition>
  <arm_group>
    <arm_group_label>Life-support Based Comprehensive Treatment Regimen group</arm_group_label>
    <description>meet all the following conditions:&#xD;
intravenous immune globulin;&#xD;
large dose of glucocorticoids;&#xD;
mechanical ventilation;&#xD;
hemodynamic support: intra-aortic balloon pump (IABP) or/and extracorporeal membrane oxygenation (ECMO);&#xD;
continuous renal replacement therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional therapy group</arm_group_label>
    <description>meet one of the following conditions:&#xD;
without/insufficient intravenous immune globulin;&#xD;
without/with various doses of glucocorticoid ;&#xD;
vasoactive drug;&#xD;
without/delayed mechanical ventilation;&#xD;
without/delayed hemodynamic support;&#xD;
without/delayed continuous renal replacement therapy.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        150 hospitalized patients with fulminant myocarditis will be enrolled in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  16 years of age or older;&#xD;
&#xD;
          -  Diagnosed as fulminant myocarditis:&#xD;
&#xD;
               -  Evidence of myocarditis on biopsy or increased biomarkers of myocardial injury&#xD;
                  (TNI and CK-MB and BNP or NT-pro-BNP);&#xD;
&#xD;
               -  Acute onset of symptoms of cardiac dysfunction: dyspnea, palpation, chest pain,&#xD;
                  and/or syncope;&#xD;
&#xD;
               -  Image for cardiac injury: marked diffused reduction in left ventricle wall&#xD;
                  movement, with dramatically decreased left ventricle ejection fraction (LVEF) &lt;&#xD;
                  45%;&#xD;
&#xD;
               -  Cardiogenic shock, e.g., systolic blood pressure ≤90 mmHg or mean arterial&#xD;
                  pressure &lt; 70mm Hg or a systolic blood pressure decrease &gt; 40 mm Hg, which is&#xD;
                  associated with the signs of hypofusion: cyanosis, cold extremities, oliguria,&#xD;
                  and/or changes in mental status.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Also considering acute coronary syndrome but unable to perform coronary angiography to&#xD;
             distinguish acute coronary syndrome from fulminant myocarditis;&#xD;
&#xD;
          -  Myocardial injury caused by sepsis, chemotherapeutical agents, or poisons;&#xD;
&#xD;
          -  Unstable hemodynamics or shock caused by hypovolemia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dao Wen Wang, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tongji Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yang Sun, MD candidate</last_name>
    <phone>86-27-83663280</phone>
    <email>d201578301@hust.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tongji Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yang Sun, MD candidate</last_name>
      <phone>86-27-83663280</phone>
      <email>d201578301@hust.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>March 10, 2020</last_update_submitted>
  <last_update_submitted_qc>March 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji Hospital</investigator_affiliation>
    <investigator_full_name>Dao Wen Wang</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Fulminant Myocarditis</keyword>
  <keyword>Retrospective cohort study</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>


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/NCT03268642
org study id: TJH-C20160202
nct id: NCT03268642
lead sponsor: 
This is a retrospective cohort study to assess the clinical outcome of patients with
      fulminant myocarditis using "Life-support Based Comprehensive Treatment Regimen" and
      conventional therapy. In the present study, participants receive various treatment as part of
      routine medical care without any assignment of specific interventions to them. The process of
      treatment during hospitalization were recorded in medical chart and was reviewed by
      independent research personnel.
observational model: Cohort
time perspective: Retrospective
measure: death or cardiac transplantation
time frame: through hospital discharge, an average of 10 days
description: The occurrence of death or cardiac transplantation was determined through direct contact with the patient or the family of the patient or review of the patient's medical record.
arm group label: Life-support Based Comprehensive Treatment Regimen group
description: meet all the following conditions:
intravenous immune globulin;
large dose of glucocorticoids;
mechanical ventilation;
hemodynamic support: intra-aortic balloon pump (IABP) or/and extracorporeal membrane oxygenation (ECMO);
continuous renal replacement therapy.
arm group label: conventional therapy group
description: meet one of the following conditions:
without/insufficient intravenous immune globulin;
without/with various doses of glucocorticoid ;
vasoactive drug;
without/delayed mechanical ventilation;
without/delayed hemodynamic support;
without/delayed continuous renal replacement therapy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Dao Wen Wang, Doctor
role: Principal Investigator
affiliation: Tongji Hospital
last name: Yang Sun, MD candidate
phone: 86-27-83663280
email: d201578301@hust.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: Dao Wen Wang
investigator title: Principal Investigator
mesh term: Myocarditis