<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/NCT02261766</url>
  </required_header>
  <id_info>
    <org_study_id>EHOT001</org_study_id>
    <nct_id>NCT02261766</nct_id>
  </id_info>
  <brief_title>Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients</brief_title>
  <acronym>EHOT</acronym>
  <official_title>Detection of Atrial Fibrillation, -Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Herlev Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Herlev Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare the two methods 5 days holtermonitoring and 30 days thumb&#xD;
      electrocardiogram for detection of atrial fibrillation in stroke patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with a newly stroke will be examined with both 5 day holter monitoring and 30 days&#xD;
      thumb ECG at the same time. The detection rates of the two methods will be compared&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Atrial fibrillation detection rate on Thumb-ECG</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation detection rate on holtermonitoring</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to detection of atrial fibrillation on holter</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to detection af atrial fibrillation on thumb-ECG</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Stroke</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Holter monitoring and Thumb ECG</intervention_name>
    <description>5 days holtermonitoring and 30 days 30 seconds twice daily thumb ECG recording</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stroke or TIA within the last 3 months verified by a CT or a MR scan or unequivocal&#xD;
             symptoms and old infarcts visualised on CT or MR&#xD;
&#xD;
          -  age 65 or above&#xD;
&#xD;
          -  patients able to handle the thumb-ECG&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  earlier diagnose of atrial fibrillation&#xD;
&#xD;
          -  pacemaker or ICD device&#xD;
&#xD;
          -  stroke induced by trauma, infection or surgery procedure&#xD;
&#xD;
          -  carotid stenosis of more than 60%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Neurology, Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>June 23, 2015</last_update_submitted>
  <last_update_submitted_qc>June 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Herlev Hospital</investigator_affiliation>
    <investigator_full_name>Karsten Overgaard</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT02261766
org study id: EHOT001
nct id: NCT02261766
lead sponsor: 
has dmc: Yes
This study will compare the two methods 5 days holtermonitoring and 30 days thumb
      electrocardiogram for detection of atrial fibrillation in stroke patients
Patients with a newly stroke will be examined with both 5 day holter monitoring and 30 days
      thumb ECG at the same time. The detection rates of the two methods will be compared
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Atrial fibrillation detection rate on Thumb-ECG
time frame: 1 month
measure: Atrial fibrillation detection rate on holtermonitoring
time frame: 5 days
measure: Time to detection of atrial fibrillation on holter
time frame: 5 days
measure: Time to detection af atrial fibrillation on thumb-ECG
time frame: 30 days
intervention type: Device
intervention name: Holter monitoring and Thumb ECG
description: 5 days holtermonitoring and 30 days 30 seconds twice daily thumb ECG recording
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Herlev Hospital
investigator full name: Karsten Overgaard
investigator title: Medical Doctor
mesh term: Stroke
mesh term: Atrial Fibrillation