<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/NCT03821051</url>
  </required_header>
  <id_info>
    <org_study_id>2017-950-1</org_study_id>
    <nct_id>NCT03821051</nct_id>
  </id_info>
  <brief_title>China Structural Ventricular Arrhythmias Registry</brief_title>
  <official_title>China Structural Ventricular Arrhythmias Registry, a Multicenter，Observational and Prospective Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China National Center for Cardiovascular Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Renmin Hospital of Wuhan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital of Nanchang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sir Run Run Shaw Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Anzhen Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital of Shenyang Military Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xuzhou Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>China National Center for Cardiovascular Diseases</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>
      This is an observational, prospective, multi-center registry ,aiming at building a risk&#xD;
      stratification for malignant structural ventricular arrhythmias. 2000 participants will be&#xD;
      recruited from 10 centers in China,with clinical data to be abstracted from medical records&#xD;
      ,and blood samples to be collected for finding promising risk indicators.The follow-up should&#xD;
      be made every 6 mouths.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In China, the prevalence and risk factors of malignant ventricular arrhythmias remain&#xD;
      unclear. In addition ,the mainstream treatment relies on implantable devices and&#xD;
      medication.China Malignant Ventricular Arrhythmias Study is a nation-wide complex consisting&#xD;
      of several interrelated studies, with the aim of building a risk stratification as well as a&#xD;
      efficient and economic strategy for early prevention and treatment.&#xD;
&#xD;
      Structural Ventricular Arrhythmias Registry, as a part of China Malignant Ventricular&#xD;
      Arrhythmias Study, is an observational, prospective, multi-center registry, aiming at&#xD;
      building a risk stratification for malignant structural ventricular arrhythmias. 2000&#xD;
      patients with definitive diagnosis will be recruited consecutively from 10 major arrhythmia&#xD;
      centers distributed in 6 areas in China. At study entry, participants will be interviewed and&#xD;
      asked to sign the informed consent. Demographic characteristics, medical history, clinical&#xD;
      features, laboratory tests, imaging pictures, medications, procedures, and in-hospital&#xD;
      outcomes of patients will be abstracted from medical records by well trained staffs .At the&#xD;
      same time, blood samples will be collected to detect biological markers, like genes,&#xD;
      inflammatory factors ,etc. Once enrolled, the participants will receive follow up every 6&#xD;
      mouths about condition of arrhythmia, medication, clinical events, etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 24, 2017</start_date>
  <completion_date type="Anticipated">October 24, 2027</completion_date>
  <primary_completion_date type="Anticipated">October 24, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>sustained tachycardia/ ventricular fibrillation or sudden cardiac death</measure>
    <time_frame>5 years</time_frame>
    <description>event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>episodes of arrhythmia</measure>
    <time_frame>5 years</time_frame>
    <description>record: type of arrhythmia, the amount of episodes, duration, unstable hemodynamics，treatment，</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>all-cause death</measure>
    <time_frame>5 years</time_frame>
    <description>exclude accidents, like trauma, drowning.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Ventricular Arrythmia</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood sample will be collected from enrolled participants to detect biomarkers, like genes,&#xD;
      inflammatory factors ,etc.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        In 10 major arrhythmia centers distributed in 6 areas in China, 2000 patients satisfying&#xD;
        the inclusion criteria will be enrolled consecutively.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed as ventricular arrhythmia resulted by structural heart diseases, including&#xD;
             ischemic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, dilated&#xD;
             cardiomyopathy, hypertrophic cardiomyopathy, etc.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yan Yao, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>China National Center for Cardiovascular Diseases</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yan Yao, MD,PhD</last_name>
    <phone>+86-13901121319</phone>
    <email>ianyao@263.net.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shangyu Liu, MD</last_name>
    <phone>+86-18800161355</phone>
    <email>liushangyu_yu_fw@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>China National Center for Cardiovascular Diseases</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Yao, MD, PhD</last_name>
      <phone>+86-13901121319</phone>
      <email>ianyao@263.net.cn</email>
    </contact>
    <contact_backup>
      <last_name>Shangyu Liu, MD</last_name>
      <phone>+86-18800161355</phone>
      <email>liushangyu_fw@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 27, 2019</last_update_submitted>
  <last_update_submitted_qc>January 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>structural ventricular arrythmia</keyword>
  <keyword>ischemic cardiomyopathy</keyword>
  <keyword>arrhythmogenic right ventricular cardiomyopathy</keyword>
  <keyword>dilated cardiomyopathy</keyword>
  <keyword>hypertrophic cardiomyopathy</keyword>
  <keyword>risk stratification</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</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/NCT03821051
org study id: 2017-950-1
nct id: NCT03821051
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an observational, prospective, multi-center registry ,aiming at building a risk
      stratification for malignant structural ventricular arrhythmias. 2000 participants will be
      recruited from 10 centers in China,with clinical data to be abstracted from medical records
      ,and blood samples to be collected for finding promising risk indicators.The follow-up should
      be made every 6 mouths.
In China, the prevalence and risk factors of malignant ventricular arrhythmias remain
      unclear. In addition ,the mainstream treatment relies on implantable devices and
      medication.China Malignant Ventricular Arrhythmias Study is a nation-wide complex consisting
      of several interrelated studies, with the aim of building a risk stratification as well as a
      efficient and economic strategy for early prevention and treatment.

      Structural Ventricular Arrhythmias Registry, as a part of China Malignant Ventricular
      Arrhythmias Study, is an observational, prospective, multi-center registry, aiming at
      building a risk stratification for malignant structural ventricular arrhythmias. 2000
      patients with definitive diagnosis will be recruited consecutively from 10 major arrhythmia
      centers distributed in 6 areas in China. At study entry, participants will be interviewed and
      asked to sign the informed consent. Demographic characteristics, medical history, clinical
      features, laboratory tests, imaging pictures, medications, procedures, and in-hospital
      outcomes of patients will be abstracted from medical records by well trained staffs .At the
      same time, blood samples will be collected to detect biological markers, like genes,
      inflammatory factors ,etc. Once enrolled, the participants will receive follow up every 6
      mouths about condition of arrhythmia, medication, clinical events, etc.
observational model: Cohort
time perspective: Prospective
measure: sustained tachycardia/ ventricular fibrillation or sudden cardiac death
time frame: 5 years
description: event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death
measure: episodes of arrhythmia
time frame: 5 years
description: record: type of arrhythmia, the amount of episodes, duration, unstable hemodynamics，treatment，
measure: all-cause death
time frame: 5 years
description: exclude accidents, like trauma, drowning.
blood sample will be collected from enrolled participants to detect biomarkers, like genes,
      inflammatory factors ,etc.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yan Yao, MD,PhD
role: Study Chair
affiliation: China National Center for Cardiovascular Diseases
last name: Yan Yao, MD,PhD
phone: +86-13901121319
email: ianyao@263.net.cn
last name: Shangyu Liu, MD
phone: +86-18800161355
email: liushangyu_yu_fw@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac