<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/NCT02204267</url>
  </required_header>
  <id_info>
    <org_study_id>MonDAFIS</org_study_id>
    <secondary_id>EA2/033/14</secondary_id>
    <nct_id>NCT02204267</nct_id>
  </id_info>
  <brief_title>Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke</brief_title>
  <acronym>MonDAFIS</acronym>
  <official_title>Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigator-initiated prospective randomized multicentre study to uncover the true burden of&#xD;
      paroxysmal atrial fibrillation in a representative population of acute stroke patients&#xD;
      without known atrial fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">October 2020</completion_date>
  <primary_completion_date type="Actual">May 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients on oral anticoagulation (NOAC or VKA)</measure>
    <time_frame>12 months</time_frame>
    <description>Number of study patients on oral anticoagulation (NOAC or VKA) at 12 months after the index stroke either randomized to standardized prolonged ECG monitoring in-hospital or those randomized to usual stroke unit diagnostic procedures alone.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of stroke patients with newly detected atrial fibrillation</measure>
    <time_frame>7 days</time_frame>
    <description>Number of stroke patients with newly detected atrial fibrillation using a standardized prolonged ECG monitoring compared to usual stroke unit diagnostic procedures alone.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Impact of stroke unit level on the rate of atrial fibrillation detection</measure>
    <time_frame>7 days</time_frame>
    <description>Impact of stroke unit level (i.e. primary or comprehensive stroke center) on the rate of atrial fibrillation detection in-hospital stroke in patients randomized to standardized prolonged ECG monitoring in hospital</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of recurrent strokes, major bleeds, myocardial infarction and all-cause death (composite endpoint) within 6, 12 and 24 months after the index stroke</measure>
    <time_frame>24 months</time_frame>
    <description>Number of recurrent strokes, major bleeds, myocardial infarction and all-cause death (composite endpoint) within 6, 12 and 24 months after the index stroke in patients either randomized to standardized prolonged ECG monitoring in-hospital or those randomized to usual stroke unit diagnostic procedures alone.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3470</enrollment>
  <condition>Stroke</condition>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>prolonged ECG monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no additional ECG recording</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Regular stroke unit treatment and diagnostic procedures according to guidelines</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>prolonged ECG monitoring</intervention_name>
    <description>Start of long-term ECG immediately after admission to the stroke unit by using a portable ECG recorder for a max. duration of 7 days (or hospital discharge)</description>
    <arm_group_label>prolonged ECG monitoring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ECG</intervention_name>
    <arm_group_label>prolonged ECG monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute ischemic stroke or transitory ischemic attack (with clinical deficit on&#xD;
             enrolment or MRI detected acute brain lesion on admission)&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Written or oral informed consent&#xD;
&#xD;
          -  Stroke unit admission within 72 hours after stroke onset&#xD;
&#xD;
          -  Start of standardized prolonged ECG monitoring within 24 hours after admission to the&#xD;
             stroke unit&#xD;
&#xD;
          -  Willingness to take part in the planned follow up examinations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known atrial fibrillation&#xD;
&#xD;
          -  Atrial fibrillation detected by ECG on admission&#xD;
&#xD;
          -  Atrial fibrillation detected prior study enrollment on the stroke unit&#xD;
&#xD;
          -  Life expectancy &lt; 1 year (before actual stroke)&#xD;
&#xD;
          -  Life expectancy &lt; 1 month (after actual stroke)&#xD;
&#xD;
          -  Indication for oral anticoagulation other than atrial fibrillation (e.g. mechanical&#xD;
             heart valve)&#xD;
&#xD;
          -  Severity level according National Institute of Health Stroke Scale (NIHSS) score &gt; 22&#xD;
&#xD;
          -  Participation in an interventional trial&#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>Matthias Endres, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Stroke Research Berlin, Charité University Berlin, Campus Mitte</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité Universitaetsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>November 11, 2020</last_update_submitted>
  <last_update_submitted_qc>November 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Matthias Endres</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>atrial fibrillation</keyword>
  <keyword>ECG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Atrial Fibrillation</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/NCT02204267
org study id: MonDAFIS
secondary id: EA2/033/14
nct id: NCT02204267
lead sponsor: 
collaborator: 
has dmc: No
Investigator-initiated prospective randomized multicentre study to uncover the true burden of
      paroxysmal atrial fibrillation in a representative population of acute stroke patients
      without known atrial fibrillation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of patients on oral anticoagulation (NOAC or VKA)
time frame: 12 months
description: Number of study patients on oral anticoagulation (NOAC or VKA) at 12 months after the index stroke either randomized to standardized prolonged ECG monitoring in-hospital or those randomized to usual stroke unit diagnostic procedures alone.
measure: Number of stroke patients with newly detected atrial fibrillation
time frame: 7 days
description: Number of stroke patients with newly detected atrial fibrillation using a standardized prolonged ECG monitoring compared to usual stroke unit diagnostic procedures alone.
measure: Impact of stroke unit level on the rate of atrial fibrillation detection
time frame: 7 days
description: Impact of stroke unit level (i.e. primary or comprehensive stroke center) on the rate of atrial fibrillation detection in-hospital stroke in patients randomized to standardized prolonged ECG monitoring in hospital
measure: Number of recurrent strokes, major bleeds, myocardial infarction and all-cause death (composite endpoint) within 6, 12 and 24 months after the index stroke
time frame: 24 months
description: Number of recurrent strokes, major bleeds, myocardial infarction and all-cause death (composite endpoint) within 6, 12 and 24 months after the index stroke in patients either randomized to standardized prolonged ECG monitoring in-hospital or those randomized to usual stroke unit diagnostic procedures alone.
arm group label: prolonged ECG monitoring
arm group type: Experimental
description: Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring
arm group label: no additional ECG recording
arm group type: No Intervention
description: Regular stroke unit treatment and diagnostic procedures according to guidelines
intervention type: Other
intervention name: prolonged ECG monitoring
description: Start of long-term ECG immediately after admission to the stroke unit by using a portable ECG recorder for a max. duration of 7 days (or hospital discharge)
arm group label: prolonged ECG monitoring
intervention type: Device
intervention name: ECG
arm group label: prolonged ECG monitoring
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthias Endres, MD
role: Principal Investigator
affiliation: Center for Stroke Research Berlin, Charité University Berlin, Campus Mitte
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Matthias Endres
investigator title: Prof. Dr. med.
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Atrial Fibrillation