<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/NCT02978248</url>
  </required_header>
  <id_info>
    <org_study_id>ARENA</org_study_id>
    <nct_id>NCT02978248</nct_id>
  </id_info>
  <brief_title>ARENA - Project Atrial Fibrilation Rhine-Neckar Region</brief_title>
  <acronym>ARENA</acronym>
  <official_title>Af Register RhEin NeckAr - Projekt Vorhofflimmern Rhein Neckar</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stiftung Institut fuer Herzinfarktforschung</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stiftung Institut fuer Herzinfarktforschung</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation.&#xD;
&#xD;
      The study design includes three study arms:&#xD;
&#xD;
        1. ARENA Intervention: This project will examine the effectiveness of population education.&#xD;
&#xD;
        2. ARENA Medication: The aim is to examine the patient's adherence and to analyze whether&#xD;
           there are any complications.&#xD;
&#xD;
        3. ARENA Migration: ARENA migration aims to examine whether a targeted population education&#xD;
           can improve the care of people with a Turkish migration background.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation.&#xD;
&#xD;
      The study design includes three study arms:&#xD;
&#xD;
        1. ARENA Intervention:&#xD;
&#xD;
           This project will examine the effectiveness of population education and other measures&#xD;
           to provide care for patients with atrial fibrillation.&#xD;
&#xD;
           In the end of the control phase (1 year recruitment of approximately 10,000 patients),&#xD;
           there will be a wide publicity, informing about the disease.&#xD;
&#xD;
        2. ARENA Medication:&#xD;
&#xD;
           ARENA records the patient's complete medication at all survey times (up to two weeks&#xD;
           after recruitment and follow up). This allows an accurate assessment of interactions&#xD;
           between individual substances.&#xD;
&#xD;
           In addition, attempts are being made to determine drug concentrations of anticoagulants&#xD;
           directly by the blood of the patient. Therefore, patients are provided with kits, which&#xD;
           they can use to apply a drop of blood from your fingertip to a filter paper. The aim is&#xD;
           to examine the patient's adherence and to analyze whether there are any complications.&#xD;
&#xD;
        3. ARENA Migration:&#xD;
&#xD;
      The Metropolregion Rhein-Neckar is characterized by a high proportion of people with a&#xD;
      Turkish migration background. ARENA migration aims to examine whether a targeted population&#xD;
      education can improve the care of this patient group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">July 19, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>1 Year</target_duration>
  <primary_outcome>
    <measure>Number of Prevented strokes in participants</measure>
    <time_frame>10 years</time_frame>
  </primary_outcome>
  <enrollment type="Actual">2777</enrollment>
  <condition>Atrial Fibrillation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with atrial fibrilation in the Rhein-Neckar Region in Germany, recruted by their&#xD;
        general practitioner or during a hospital stay.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willingness to participate&#xD;
&#xD;
          -  Atiral fibrilation&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not willing to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Borggrefe, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsmedizin Mannheim</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Walter E. Haefeli, Prof. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Heidelberg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ömer Sanatci, Dr. med.</last_name>
    <role>Study Chair</role>
    <affiliation>Praxis Merz Sanatci</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden-Württemberg</state>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 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>Atrial Fibrillation</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/NCT02978248
org study id: ARENA
nct id: NCT02978248
lead sponsor: 
has dmc: No
ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation.

      The study design includes three study arms:

        1. ARENA Intervention: This project will examine the effectiveness of population education.

        2. ARENA Medication: The aim is to examine the patient's adherence and to analyze whether
           there are any complications.

        3. ARENA Migration: ARENA migration aims to examine whether a targeted population education
           can improve the care of people with a Turkish migration background.
ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation.

      The study design includes three study arms:

        1. ARENA Intervention:

           This project will examine the effectiveness of population education and other measures
           to provide care for patients with atrial fibrillation.

           In the end of the control phase (1 year recruitment of approximately 10,000 patients),
           there will be a wide publicity, informing about the disease.

        2. ARENA Medication:

           ARENA records the patient's complete medication at all survey times (up to two weeks
           after recruitment and follow up). This allows an accurate assessment of interactions
           between individual substances.

           In addition, attempts are being made to determine drug concentrations of anticoagulants
           directly by the blood of the patient. Therefore, patients are provided with kits, which
           they can use to apply a drop of blood from your fingertip to a filter paper. The aim is
           to examine the patient's adherence and to analyze whether there are any complications.

        3. ARENA Migration:

      The Metropolregion Rhein-Neckar is characterized by a high proportion of people with a
      Turkish migration background. ARENA migration aims to examine whether a targeted population
      education can improve the care of this patient group.
observational model: Cohort
time perspective: Prospective
measure: Number of Prevented strokes in participants
time frame: 10 years
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Martin Borggrefe, Prof. Dr.
role: Principal Investigator
affiliation: Universitätsmedizin Mannheim
last name: Walter E. Haefeli, Prof. Dr.
role: Study Chair
affiliation: University Hospital Heidelberg
last name: Ömer Sanatci, Dr. med.
role: Study Chair
affiliation: Praxis Merz Sanatci
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No