<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/NCT02982473</url>
  </required_header>
  <id_info>
    <org_study_id>2016-612N-MA</org_study_id>
    <nct_id>NCT02982473</nct_id>
  </id_info>
  <brief_title>Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions</brief_title>
  <acronym>RACE-IT</acronym>
  <official_title>Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsmedizin Mannheim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsmedizin Mannheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The &quot;Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics&#xD;
      and Interventions (RACE-IT)&quot; represents a mono-centric registry of patients being&#xD;
      hospitalized suffering from malignant arrythmias (ventricular tachycardia or fibrillation)&#xD;
      and sudden cardiac death (SCD).&#xD;
&#xD;
      Detailed findings of patients' clinical outcome regarding mortality and co-morbidities&#xD;
      related to the presence of invasive diagnostics or therapies including coronary angiography,&#xD;
      percutaneous coronary intervention (PCI), electrophysiological testing (EP), catheter&#xD;
      ablation and implanted cardiac devices (e.g. implantable cardioverter-defibrillators) will be&#xD;
      documented. Patients will be included when being hospitalized from the year 2004 until today.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Incidence of ventricular arrythmias (i.e. ventricular fibrillation, ventricular tachykardia, asystole, SCD)</measure>
    <time_frame>Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of coronary artery disease (CAD) and PCI in patients with VF/VT/SCD</measure>
    <time_frame>Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of invasive electrophysiologic testing (EP) and catheter ablation</measure>
    <time_frame>Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment with cardiac devices (i.e. ICD, CCM, CRT-D)</measure>
    <time_frame>Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidences of recurrent malignant tachycardias, all-cause mortality, arrhythmia-related death, re-PCI/ACVB, re-ablation, further therapy with cardiac devices</measure>
    <time_frame>Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">3200</enrollment>
  <condition>Ventricular Tachycardia</condition>
  <condition>Ventricular Fibrillation</condition>
  <condition>Sudden Cardiac Death</condition>
  <condition>Coronary Angiography</condition>
  <condition>Electrophysiologic Testing (EP)</condition>
  <condition>Catheter Ablation</condition>
  <condition>Percutaneous Coronary Intervention (PCI)</condition>
  <condition>Internal Cardioverter Defibrillator (ICD)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients being hospitalized with diagnoses of ventricular tachycardia, ventricular&#xD;
        fibrillation and/or sudden cardiac death at the First Department of Medicine, University&#xD;
        Medical Centre Mannheim, Germany.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Hospitalization due to:&#xD;
&#xD;
          -  ventricular tachycardia&#xD;
&#xD;
          -  ventricular fibrillation&#xD;
&#xD;
          -  sudden cardiac death&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not diagnosed with one or more of the above&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ibrahim Akin, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Deparment of Medicine, University Medical Centre Mannheim (UMM), Germany; Theodor-Kutzer-Ufer 1-3; 61867 Mannheim, Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ibrahim Akin, Prof. Dr.</last_name>
    <phone>+49 621 383 5229</phone>
    <email>ibrahim.akin@umm.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael Behnes, Dr. med.</last_name>
    <phone>+49 621 383 6239</phone>
    <email>michael.behnes@umm.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>First Department of Medicine, University Medical Centre Mannheim</name>
      <address>
        <city>Mannheim</city>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ibrahim Akin, MD, PhD</last_name>
      <email>ibrahim.akin@umm.de</email>
    </contact>
    <contact_backup>
      <last_name>Michael Behnes, MD</last_name>
      <email>michael.behnes@umm.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>August 26, 2020</last_update_submitted>
  <last_update_submitted_qc>August 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitätsmedizin Mannheim</investigator_affiliation>
    <investigator_full_name>Michael Behnes</investigator_full_name>
    <investigator_title>Sub-PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Ventricular</mesh_term>
    <mesh_term>Death, Sudden, Cardiac</mesh_term>
    <mesh_term>Ventricular Fibrillation</mesh_term>
    <mesh_term>Death</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02982473
org study id: 2016-612N-MA
nct id: NCT02982473
lead sponsor: 
has dmc: No
The "Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics
      and Interventions (RACE-IT)" represents a mono-centric registry of patients being
      hospitalized suffering from malignant arrythmias (ventricular tachycardia or fibrillation)
      and sudden cardiac death (SCD).

      Detailed findings of patients' clinical outcome regarding mortality and co-morbidities
      related to the presence of invasive diagnostics or therapies including coronary angiography,
      percutaneous coronary intervention (PCI), electrophysiological testing (EP), catheter
      ablation and implanted cardiac devices (e.g. implantable cardioverter-defibrillators) will be
      documented. Patients will be included when being hospitalized from the year 2004 until today.
observational model: Cohort
time perspective: Retrospective
measure: Incidence of ventricular arrythmias (i.e. ventricular fibrillation, ventricular tachykardia, asystole, SCD)
time frame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime
measure: Incidence of coronary artery disease (CAD) and PCI in patients with VF/VT/SCD
time frame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime
measure: Incidence of invasive electrophysiologic testing (EP) and catheter ablation
time frame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime
measure: Incidence of treatment with cardiac devices (i.e. ICD, CCM, CRT-D)
time frame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime
measure: Incidences of recurrent malignant tachycardias, all-cause mortality, arrhythmia-related death, re-PCI/ACVB, re-ablation, further therapy with cardiac devices
time frame: Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ibrahim Akin, Prof. Dr.
role: Principal Investigator
affiliation: First Deparment of Medicine, University Medical Centre Mannheim (UMM), Germany; Theodor-Kutzer-Ufer 1-3; 61867 Mannheim, Germany
last name: Ibrahim Akin, Prof. Dr.
phone: +49 621 383 5229
email: ibrahim.akin@umm.de
last name: Michael Behnes, Dr. med.
phone: +49 621 383 6239
email: michael.behnes@umm.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Universitätsmedizin Mannheim
investigator full name: Michael Behnes
investigator title: Sub-PI
mesh term: Tachycardia
mesh term: Tachycardia, Ventricular
mesh term: Death, Sudden, Cardiac
mesh term: Ventricular Fibrillation
mesh term: Death
sharing ipd: No