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/NCT06002750</url>
    </required_header>
    <id_info>
      <org_study_id>2021KA048</org_study_id>
      <nct_id>NCT06002750</nct_id>
    </id_info>
    <brief_title>Evaluation of Tp-e Interval and Tp-e/QT Ratio in Dermatomyositis and Analysis of Their Relationship With Inflammation</brief_title>
    <official_title>The Third People's Hospital of Hangzhou</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Third People's Hospital of Hangzhou</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Third People's Hospital of Hangzhou</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 goal of this observational study is to investigate ventricular repolarization utilizing&#xD;
        Tp-e intervals and Tp-e/QT ratios in patients with DM. The main questions it aims to answer&#xD;
        are:&#xD;
  &#xD;
          -  1.Exploring the changes in ventricular repolarization parameters (QT interval, QTc&#xD;
             interval, QTd, Tp-e interval, Tp-e/QT ratio) in patients with dermatomyositis, providing&#xD;
             quantifiable indicators for early detection of arrhythmia in dermatomyositis patients;&#xD;
  &#xD;
          -  2.Exploring the role of inflammation in ventricular repolarization in DM patients,&#xD;
             providing a basis for in-depth research on the diagnosis and prevention of arrhythmia in&#xD;
             DM patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Anticipated">August 2023</completion_date>
    <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>QTc, Tp-e interval, and Tp-e/QT ratio were increased in DM patients.</measure>
      <time_frame>January 2017 to October 2022</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>the Tp-e interval and Tp-e/QT ratio were positively correlated with Inflammation.</measure>
      <time_frame>January 2017 to October 2022</time_frame>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">280</enrollment>
    <condition>Dermatomyositis</condition>
    <condition>Myocardial Repolarization</condition>
    <condition>Inflammation</condition>
    <arm_group>
      <arm_group_label>Dermatomyositis patients</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>The control group was comprised of age- and gender-matched healthy volunteers</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Dermatomyositis patients from January 2017 to October 2022 who visited our hospital, and a&#xD;
          healthy control group consisting of the same number of gender and age matched healthy&#xD;
          adults in a physical examination center.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Regardless of gender, registered residence and education level, voluntarily participate in&#xD;
          this study and sign the informed consent form.&#xD;
  &#xD;
          Clinical diagnosis of Dermatomyositis.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Previous history of heart disease (such as myocardial infarction, cardiac pacing,&#xD;
          congenital heart disease, ischemic heart disease, etc.), chronic kidney disease, etc;&#xD;
          Patients with other connective tissue diseases; Pregnant and lactating women.&#xD;
  &#xD;
          Taking drugs that affect electrocardiogram indicators, such as macrolides, quinolones,&#xD;
          quinidine, amiodarone, antipsychotic drugs, etc.&#xD;
  &#xD;
          Patients with severe lack of case data.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>The Third People's Hospital of Hangzhou</name>
        <address>
          <city>Zhejiang</city>
          <state>Hangzhou</state>
          <zip>310000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ping Lin</last_name>
        <phone>15868809750</phone>
        <email>wh892699771@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Lundberg IE. Expert Perspective: Management of Refractory Inflammatory Myopathy. Arthritis Rheumatol. 2021 Aug;73(8):1394-1407. doi: 10.1002/art.41762. Epub 2021 Jun 29.</citation>
      <PMID>33844450</PMID>
    </reference>
    <reference>
      <citation>Zhao L, Wang Q, Zhou B, Zhang L, Zhu H. The Role of Immune Cells in the Pathogenesis of Idiopathic Inflammatory Myopathies. Aging Dis. 2021 Feb 1;12(1):247-260. doi: 10.14336/AD.2020.0410. eCollection 2021 Feb.</citation>
      <PMID>33532139</PMID>
    </reference>
    <reference>
      <citation>Schwartz T, Diederichsen LP, Lundberg IE, Sjaastad I, Sanner H. Cardiac involvement in adult and juvenile idiopathic inflammatory myopathies. RMD Open. 2016 Sep 27;2(2):e000291. doi: 10.1136/rmdopen-2016-000291. eCollection 2016.</citation>
      <PMID>27752355</PMID>
    </reference>
    <reference>
      <citation>Kors JA, Ritsema van Eck HJ, van Herpen G. The meaning of the Tp-Te interval and its diagnostic value. J Electrocardiol. 2008 Nov-Dec;41(6):575-80. doi: 10.1016/j.jelectrocard.2008.07.030.</citation>
      <PMID>18954608</PMID>
    </reference>
    <reference>
      <citation>Antzelevitch C, Sicouri S, Di Diego JM, Burashnikov A, Viskin S, Shimizu W, Yan GX, Kowey P, Zhang L. Does Tpeak-Tend provide an index of transmural dispersion of repolarization? Heart Rhythm. 2007 Aug;4(8):1114-6; author reply 1116-9. doi: 10.1016/j.hrthm.2007.05.028. Epub 2007 Jun 8. No abstract available.</citation>
      <PMID>17675094</PMID>
    </reference>
    <reference>
      <citation>Naaraayan A, Meredith A, Nimkar A, Arora G, Bharati R, Acharya P. Arrhythmia prevalence among patients with polymyositis-dermatomyositis in the United States: An observational study. Heart Rhythm. 2021 Sep;18(9):1516-1523. doi: 10.1016/j.hrthm.2021.05.029. Epub 2021 May 26.</citation>
      <PMID>34048962</PMID>
    </reference>
    <reference>
      <citation>Indraratna P, Tardo D, Delves M, Szirt R, Ng B. Measurement and Management of QT Interval Prolongation for General Physicians. J Gen Intern Med. 2020 Mar;35(3):865-873. doi: 10.1007/s11606-019-05477-7. Epub 2019 Oct 25.</citation>
      <PMID>31654357</PMID>
    </reference>
    <reference>
      <citation>Korsholm SS, Andersson DC, Knudsen JB, Dastmalchi M, Diederichsen ACP, Gerke O, Witting N, Jacobsen S, Pecini R, Friis T, Krogager ME, Lundberg IE, Diederichsen LP. Myositis-specific autoantibodies and QTc changes by ECG in idiopathic inflammatory myopathies. Rheumatology (Oxford). 2022 Oct 6;61(10):4076-4086. doi: 10.1093/rheumatology/keac013.</citation>
      <PMID>35048961</PMID>
    </reference>
    <reference>
      <citation>Mendez Hernandez R, Ramasco Rueda F. Biomarkers as Prognostic Predictors and Therapeutic Guide in Critically Ill Patients: Clinical Evidence. J Pers Med. 2023 Feb 15;13(2):333. doi: 10.3390/jpm13020333.</citation>
      <PMID>36836567</PMID>
    </reference>
    <reference>
      <citation>Lazzerini PE, Capecchi PL, El-Sherif N, Laghi-Pasini F, Boutjdir M. Emerging Arrhythmic Risk of Autoimmune and Inflammatory Cardiac Channelopathies. J Am Heart Assoc. 2018 Nov 20;7(22):e010595. doi: 10.1161/JAHA.118.010595. No abstract available.</citation>
      <PMID>30571503</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dermatomyositis</mesh_term>
      <mesh_term>Inflammation</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/NCT06002750
  org study id: 2021KA048
  nct id: NCT06002750
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to investigate ventricular repolarization utilizing
        Tp-e intervals and Tp-e/QT ratios in patients with DM. The main questions it aims to answer
        are:
  
          -  1.Exploring the changes in ventricular repolarization parameters (QT interval, QTc
             interval, QTd, Tp-e interval, Tp-e/QT ratio) in patients with dermatomyositis, providing
             quantifiable indicators for early detection of arrhythmia in dermatomyositis patients;
  
          -  2.Exploring the role of inflammation in ventricular repolarization in DM patients,
             providing a basis for in-depth research on the diagnosis and prevention of arrhythmia in
             DM patients.
  observational model: Other
  time perspective: Retrospective
  measure: QTc, Tp-e interval, and Tp-e/QT ratio were increased in DM patients.
  time frame: January 2017 to October 2022
  measure: the Tp-e interval and Tp-e/QT ratio were positively correlated with Inflammation.
  time frame: January 2017 to October 2022
  arm group label: Dermatomyositis patients
  arm group label: The control group was comprised of age- and gender-matched healthy volunteers
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: Lundberg IE. Expert Perspective: Management of Refractory Inflammatory Myopathy. Arthritis Rheumatol. 2021 Aug;73(8):1394-1407. doi: 10.1002/art.41762. Epub 2021 Jun 29.
  PMID: 33844450
  citation: Zhao L, Wang Q, Zhou B, Zhang L, Zhu H. The Role of Immune Cells in the Pathogenesis of Idiopathic Inflammatory Myopathies. Aging Dis. 2021 Feb 1;12(1):247-260. doi: 10.14336/AD.2020.0410. eCollection 2021 Feb.
  PMID: 33532139
  citation: Schwartz T, Diederichsen LP, Lundberg IE, Sjaastad I, Sanner H. Cardiac involvement in adult and juvenile idiopathic inflammatory myopathies. RMD Open. 2016 Sep 27;2(2):e000291. doi: 10.1136/rmdopen-2016-000291. eCollection 2016.
  PMID: 27752355
  citation: Kors JA, Ritsema van Eck HJ, van Herpen G. The meaning of the Tp-Te interval and its diagnostic value. J Electrocardiol. 2008 Nov-Dec;41(6):575-80. doi: 10.1016/j.jelectrocard.2008.07.030.
  PMID: 18954608
  citation: Antzelevitch C, Sicouri S, Di Diego JM, Burashnikov A, Viskin S, Shimizu W, Yan GX, Kowey P, Zhang L. Does Tpeak-Tend provide an index of transmural dispersion of repolarization? Heart Rhythm. 2007 Aug;4(8):1114-6; author reply 1116-9. doi: 10.1016/j.hrthm.2007.05.028. Epub 2007 Jun 8. No abstract available.
  PMID: 17675094
  citation: Naaraayan A, Meredith A, Nimkar A, Arora G, Bharati R, Acharya P. Arrhythmia prevalence among patients with polymyositis-dermatomyositis in the United States: An observational study. Heart Rhythm. 2021 Sep;18(9):1516-1523. doi: 10.1016/j.hrthm.2021.05.029. Epub 2021 May 26.
  PMID: 34048962
  citation: Indraratna P, Tardo D, Delves M, Szirt R, Ng B. Measurement and Management of QT Interval Prolongation for General Physicians. J Gen Intern Med. 2020 Mar;35(3):865-873. doi: 10.1007/s11606-019-05477-7. Epub 2019 Oct 25.
  PMID: 31654357
  citation: Korsholm SS, Andersson DC, Knudsen JB, Dastmalchi M, Diederichsen ACP, Gerke O, Witting N, Jacobsen S, Pecini R, Friis T, Krogager ME, Lundberg IE, Diederichsen LP. Myositis-specific autoantibodies and QTc changes by ECG in idiopathic inflammatory myopathies. Rheumatology (Oxford). 2022 Oct 6;61(10):4076-4086. doi: 10.1093/rheumatology/keac013.
  PMID: 35048961
  citation: Mendez Hernandez R, Ramasco Rueda F. Biomarkers as Prognostic Predictors and Therapeutic Guide in Critically Ill Patients: Clinical Evidence. J Pers Med. 2023 Feb 15;13(2):333. doi: 10.3390/jpm13020333.
  PMID: 36836567
  citation: Lazzerini PE, Capecchi PL, El-Sherif N, Laghi-Pasini F, Boutjdir M. Emerging Arrhythmic Risk of Autoimmune and Inflammatory Cardiac Channelopathies. J Am Heart Assoc. 2018 Nov 20;7(22):e010595. doi: 10.1161/JAHA.118.010595. No abstract available.
  PMID: 30571503
  responsible party type: Sponsor
  mesh term: Dermatomyositis
  mesh term: Inflammation