<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/NCT04498494</url>
  </required_header>
  <id_info>
    <org_study_id>Yuanli2020</org_study_id>
    <nct_id>NCT04498494</nct_id>
  </id_info>
  <brief_title>The Role of Electrocardiograms in Risk Stratification and Analysis of the Characteristics of ST Elevation in Acute Myocarditis: a 2-centre Study</brief_title>
  <official_title>Role of Electrocardiograms in Risk Stratification and Analysis of the Characteristics of ST Elevation in Acute Myocarditis: A Two-center Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuanli Lei</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of the present study was to investigate ECG findings of patients with acute&#xD;
      myocarditis, ECG findings associated with fulminant myocarditis, and the characteristics of&#xD;
      ST-elevation on admission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute myocarditis is a severe disease with high mortality rate and various dynamic changes&#xD;
      visible on electrocardiograms (ECGs). The aim were to investigate ECG findings in acute&#xD;
      myocarditis, ECG findings associated with fulminant myocarditis (FM), and the characteristics&#xD;
      of ST elevation at admission. A retrospective analysis of 1814 ECGs was conducted from 274&#xD;
      consecutive patients with acute myocarditis aged ≥13 years, who were hospitalized in two&#xD;
      centres between August 2007 and November 2019. All ECG obtained during the hospital course&#xD;
      were evaluated by 2 electrophysiologists. A chi-square test was used to evaluate and compare&#xD;
      the abnormal ECG findings between the FM and non-FM groups, and multivariate logistic&#xD;
      regression analysis was performed to further evaluate ECG findings associated with FM. The&#xD;
      Mann-Whitney U test was used to compare the duration of cardiac symptoms before admission for&#xD;
      ST elevation at admission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage rate of ST elevation</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>ST elevation was the typical ECG changes of acute myocarditis. The study was to investigate how many patients presented with ST elevation on admission.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Atrioventricular block, ventricular tachycardia and their correlationwith Fulminant myocarditis (FM)</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>FM is a peculiar clinical condition and is an acute and severe form of myocarditis . FM is associated with a wide variety of ECG findings. The study was to investigate Atrioventricular block, ventricular tachycardia and their correlation with FM.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">274</enrollment>
  <condition>Myocarditis</condition>
  <arm_group>
    <arm_group_label>myocarditis</arm_group_label>
    <description>The diagnosis of acute myocarditis was confirmed by a recent history of gastrointestinal/upper respiratory tract infection and/or complaints of cardiac symptoms and increasing cardiac markers and/or presentation with a new abnormality of the 12-lead ECGcombined with at least one of the following: ⅰ) Active or borderline biopsy according to the Dallas criteria (13); ⅱ) positive infectious origin of ventricular dysfunction; ⅲ) delayed enhancement on cardiac MRI consistent with myocarditis; or ⅳ) serological tests, ECGs, ultrasonic cardiogram (UCG), coronary angiography and ventriculography to exclude acute myocardial infarction (AMI), stress cardiomyopathy, congenital heart disease, myocarditis secondary to sepsis, valve disease, hyperthyroidism, autoimmune disease and rheumatic fever</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fulminant myocarditis</arm_group_label>
    <description>In patients with acute myocarditis, a diagnosis of FM was determined upon identification of one or more of the following: Haemodynamic instability due to cardiogenic shock or arrhythmia; left ventricular dysfunction and low cardiac output syndrome requiring inotropes or mechanical circulatory support; mechanical ventilation; and/or cardiac arrest (CA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ECG</intervention_name>
    <description>12-lead ECG</description>
    <arm_group_label>fulminant myocarditis</arm_group_label>
    <arm_group_label>myocarditis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        20 million residents of the South of Zhejiang Province&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of Acute myocarditis&#xD;
&#xD;
               -  complete data of ECG&#xD;
&#xD;
        Exclusion Criteria :&#xD;
&#xD;
          -  Incomplete data;&#xD;
&#xD;
               -  a history of congenital heart disease, cardiomyopathy or arrhythmias;&#xD;
&#xD;
                    -  myocarditis not being the primary diagnosis for a particular admission;&#xD;
&#xD;
                         -  absence of cardiac symptoms.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Wenzhou Medical University</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>JCS Joint Working Group. Guidelines for diagnosis and treatment of myocarditis (JCS 2009): digest version. Circ J. 2011;75(3):734-43. doi: 10.1253/circj.cj-88-0008. Epub 2011 Feb 4. No abstract available.</citation>
    <PMID>21304213</PMID>
  </reference>
  <reference>
    <citation>Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Helio T, Heymans S, Jahns R, Klingel K, Linhart A, Maisch B, McKenna W, Mogensen J, Pinto YM, Ristic A, Schultheiss HP, Seggewiss H, Tavazzi L, Thiene G, Yilmaz A, Charron P, Elliott PM; European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013 Sep;34(33):2636-48, 2648a-2648d. doi: 10.1093/eurheartj/eht210. Epub 2013 Jul 3.</citation>
    <PMID>23824828</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>Yuanli Lei</investigator_full_name>
    <investigator_title>principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT04498494
org study id: Yuanli2020
nct id: NCT04498494
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the present study was to investigate ECG findings of patients with acute
      myocarditis, ECG findings associated with fulminant myocarditis, and the characteristics of
      ST-elevation on admission.
Acute myocarditis is a severe disease with high mortality rate and various dynamic changes
      visible on electrocardiograms (ECGs). The aim were to investigate ECG findings in acute
      myocarditis, ECG findings associated with fulminant myocarditis (FM), and the characteristics
      of ST elevation at admission. A retrospective analysis of 1814 ECGs was conducted from 274
      consecutive patients with acute myocarditis aged ≥13 years, who were hospitalized in two
      centres between August 2007 and November 2019. All ECG obtained during the hospital course
      were evaluated by 2 electrophysiologists. A chi-square test was used to evaluate and compare
      the abnormal ECG findings between the FM and non-FM groups, and multivariate logistic
      regression analysis was performed to further evaluate ECG findings associated with FM. The
      Mann-Whitney U test was used to compare the duration of cardiac symptoms before admission for
      ST elevation at admission.
observational model: Case-Control
time perspective: Retrospective
measure: The percentage rate of ST elevation
time frame: through study completion, an average of 2 years
description: ST elevation was the typical ECG changes of acute myocarditis. The study was to investigate how many patients presented with ST elevation on admission.
measure: Atrioventricular block, ventricular tachycardia and their correlationwith Fulminant myocarditis (FM)
time frame: through study completion, an average of 6 months
description: FM is a peculiar clinical condition and is an acute and severe form of myocarditis . FM is associated with a wide variety of ECG findings. The study was to investigate Atrioventricular block, ventricular tachycardia and their correlation with FM.
arm group label: myocarditis
description: The diagnosis of acute myocarditis was confirmed by a recent history of gastrointestinal/upper respiratory tract infection and/or complaints of cardiac symptoms and increasing cardiac markers and/or presentation with a new abnormality of the 12-lead ECGcombined with at least one of the following: ⅰ) Active or borderline biopsy according to the Dallas criteria (13); ⅱ) positive infectious origin of ventricular dysfunction; ⅲ) delayed enhancement on cardiac MRI consistent with myocarditis; or ⅳ) serological tests, ECGs, ultrasonic cardiogram (UCG), coronary angiography and ventriculography to exclude acute myocardial infarction (AMI), stress cardiomyopathy, congenital heart disease, myocarditis secondary to sepsis, valve disease, hyperthyroidism, autoimmune disease and rheumatic fever
arm group label: fulminant myocarditis
description: In patients with acute myocarditis, a diagnosis of FM was determined upon identification of one or more of the following: Haemodynamic instability due to cardiogenic shock or arrhythmia; left ventricular dysfunction and low cardiac output syndrome requiring inotropes or mechanical circulatory support; mechanical ventilation; and/or cardiac arrest (CA)
intervention type: Device
intervention name: ECG
description: 12-lead ECG
arm group label: fulminant myocarditis
arm group label: myocarditis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: China
citation: JCS Joint Working Group. Guidelines for diagnosis and treatment of myocarditis (JCS 2009): digest version. Circ J. 2011;75(3):734-43. doi: 10.1253/circj.cj-88-0008. Epub 2011 Feb 4. No abstract available.
PMID: 21304213
citation: Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Helio T, Heymans S, Jahns R, Klingel K, Linhart A, Maisch B, McKenna W, Mogensen J, Pinto YM, Ristic A, Schultheiss HP, Seggewiss H, Tavazzi L, Thiene G, Yilmaz A, Charron P, Elliott PM; European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013 Sep;34(33):2636-48, 2648a-2648d. doi: 10.1093/eurheartj/eht210. Epub 2013 Jul 3.
PMID: 23824828
responsible party type: Sponsor-Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: Yuanli Lei
investigator title: principal Investigator
mesh term: Myocarditis