<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/NCT03272620</url>
  </required_header>
  <id_info>
    <org_study_id>98765</org_study_id>
    <nct_id>NCT03272620</nct_id>
  </id_info>
  <brief_title>Atrial Fibrillation at the Viennese University Emergency Department</brief_title>
  <official_title>Atrial Fibrillation Registry at the Emergency Department of the Medical University of Vienna: A Tool for Structured Diagnosis and Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The results of this study could imply that a atrial fibrillation registry, as a tool for&#xD;
      structured diagnosis and therapy in patients with atrial fibrillation, may improve patient&#xD;
      care for this rapidly growing population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atrial fibrillation is the most common cardiac arrhythmia and is associated with increased&#xD;
      cardiovascular morbidity and mortality, with stroke being an especially important and&#xD;
      potentially devastating complication. The number of patients with atrial fibrillation is&#xD;
      likely to increase 2.5-fold during the next 50 years, reflecting the growing proportion of&#xD;
      elderly individuals. Emergency departments play a central role in diagnosis and treatment&#xD;
      (rhythm and rate control, initiation of anticoagulatory therapy for stroke prevention) of&#xD;
      atrial fibrillation. Additionally, embolic (e.g. stroke, mesenteric ischemia) complications&#xD;
      of atrial fibrillation and bleeding complications (e.g. gastrointestinal and intracranial) of&#xD;
      anticoagulatory therapy are likewise treated at emergency departments.&#xD;
&#xD;
      Therefor the investigators hypothesis implies that the atrial fibrillation registry could&#xD;
      serve as a tool for structured diagnosis and therapy in patients with atrial fibrillation and&#xD;
      therefore may improve patient care. Additionally, diagnostic and therapeutic shortcomings by&#xD;
      analyzing registry data may be detected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 22, 2014</start_date>
  <completion_date type="Anticipated">January 1, 2030</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>10 Years</target_duration>
  <primary_outcome>
    <measure>Number of participants with major adverse cardiac events</measure>
    <time_frame>Follow up (10 years)</time_frame>
    <description>frequency distribution</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of successfully conducted cardioversions</measure>
    <time_frame>Follow up (10 years)</time_frame>
    <description>frequency distribution</description>
  </secondary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Atrial Flutter</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with atrial fibrillation treated at the Emergency Department of the Vienna Medical&#xD;
        University. Currently, about 600 patients with atrial fibrillation are seen annually at the&#xD;
        Emergency Department, every patient with atrial fibrillation treated at the Emergency&#xD;
        Department should be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with atrial fibrillation treated at the Emergency Department of the Medical&#xD;
             University of Vienna&#xD;
&#xD;
          -  Signed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria not met&#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>Alexander Spiel, Priv. Doz.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Vienna</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jan Niederdöckl, Dr.</last_name>
    <email>jan.niederdöckl@meduniwien.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alexander Simon, Dr.</last_name>
    <email>alexander.simon@meduniwien.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Emergency Department, Medical University Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan Niederdöckl, Dr.</last_name>
      <email>jan.niederdoeckl@medunwien.ac.at</email>
    </contact>
    <contact_backup>
      <last_name>Alexander Simon, Dr.</last_name>
      <email>alexander.simon@medunwien.ac.at</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <reference>
    <citation>Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.</citation>
    <PMID>11343485</PMID>
  </reference>
  <reference>
    <citation>Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomized controlled trials. Arch Intern Med. 1994 Jul 11;154(13):1449-57. Erratum In: Arch Intern Med 1994 Oct 10;154(19):2254.</citation>
    <PMID>8018000</PMID>
  </reference>
  <reference>
    <citation>Lip GY, Tean KN, Dunn FG. Treatment of atrial fibrillation in a district general hospital. Br Heart J. 1994 Jan;71(1):92-5. doi: 10.1136/hrt.71.1.92.</citation>
    <PMID>8297706</PMID>
  </reference>
  <reference>
    <citation>Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.</citation>
    <PMID>9737513</PMID>
  </reference>
  <reference>
    <citation>O'Reilly DJ, Hopkins RB, Healey JS, Dorian P, Sauriol L, Tarride JE, Burke N, Goeree RA. The burden of atrial fibrillation on the hospital sector in Canada. Can J Cardiol. 2013 Feb;29(2):229-35. doi: 10.1016/j.cjca.2012.03.023. Epub 2012 May 30.</citation>
    <PMID>22652091</PMID>
  </reference>
  <reference>
    <citation>Domanovits H, Schillinger M, Thoennissen J, Nikfardjam M, Janata K, Brunner M, Laggner AN. Termination of recent-onset atrial fibrillation/flutter in the emergency department: a sequential approach with intravenous ibutilide and external electrical cardioversion. Resuscitation. 2000 Aug 1;45(3):181-7. doi: 10.1016/s0300-9572(00)00180-5.</citation>
    <PMID>10959017</PMID>
  </reference>
  <reference>
    <citation>Vinson DR, Hoehn T, Graber DJ, Williams TM. Managing emergency department patients with recent-onset atrial fibrillation. J Emerg Med. 2012 Feb;42(2):139-48. doi: 10.1016/j.jemermed.2010.05.017. Epub 2010 Jul 15.</citation>
    <PMID>20634022</PMID>
  </reference>
  <reference>
    <citation>von Besser K, Mills AM. Is discharge to home after emergency department cardioversion safe for the treatment of recent-onset atrial fibrillation? Ann Emerg Med. 2011 Dec;58(6):517-20. doi: 10.1016/j.annemergmed.2011.06.014. Epub 2011 Jul 29.</citation>
    <PMID>22098994</PMID>
  </reference>
  <reference>
    <citation>Bellone A, Etteri M, Vettorello M, Bonetti C, Clerici D, Gini G, Maino C, Mariani M, Natalizi A, Nessi I, Rampoldi A, Colombo L. Cardioversion of acute atrial fibrillation in the emergency department: a prospective randomised trial. Emerg Med J. 2012 Mar;29(3):188-91. doi: 10.1136/emj.2010.109702. Epub 2011 Mar 21.</citation>
    <PMID>21422032</PMID>
  </reference>
  <reference>
    <citation>Hochtl T, Huber K. New anticoagulants for the prevention of stroke in atrial fibrillation. Fundam Clin Pharmacol. 2012 Feb;26(1):47-53. doi: 10.1111/j.1472-8206.2011.00982.x. Epub 2011 Aug 29.</citation>
    <PMID>21883447</PMID>
  </reference>
  <reference>
    <citation>Oldgren J, Healey JS, Ezekowitz M, Commerford P, Avezum A, Pais P, Zhu J, Jansky P, Sigamani A, Morillo CA, Liu L, Damasceno A, Grinvalds A, Nakamya J, Reilly PA, Keltai K, Van Gelder IC, Yusufali AH, Watanabe E, Wallentin L, Connolly SJ, Yusuf S; RE-LY Atrial Fibrillation Registry Investigators. Variations in cause and management of atrial fibrillation in a prospective registry of 15,400 emergency department patients in 46 countries: the RE-LY Atrial Fibrillation Registry. Circulation. 2014 Apr 15;129(15):1568-76. doi: 10.1161/CIRCULATIONAHA.113.005451. Epub 2014 Jan 24. Erratum In: Circulation. 2015 Feb 17;131(7):e352.</citation>
    <PMID>24463370</PMID>
  </reference>
  <reference>
    <citation>Rovellini A, Folli C, Cardani F, Monzani V. Thromboembolic and haemorrhagic events in permanent atrial fibrillation: observational study in an emergency department. Eur J Intern Med. 2009 Dec;20(8):756-9. doi: 10.1016/j.ejim.2009.08.008. Epub 2009 Sep 24.</citation>
    <PMID>19892303</PMID>
  </reference>
  <reference>
    <citation>Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines-CPG; Document Reviewers. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation--developed with the special contribution of the European Heart Rhythm Association. Europace. 2012 Oct;14(10):1385-413. doi: 10.1093/europace/eus305. Epub 2012 Aug 24. No abstract available.</citation>
    <PMID>22923145</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Alexander Spiel</investigator_full_name>
    <investigator_title>Associate Professor at the Department of Emergency Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Atrial Flutter</mesh_term>
    <mesh_term>Emergencies</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/NCT03272620
org study id: 98765
nct id: NCT03272620
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The results of this study could imply that a atrial fibrillation registry, as a tool for
      structured diagnosis and therapy in patients with atrial fibrillation, may improve patient
      care for this rapidly growing population.
Atrial fibrillation is the most common cardiac arrhythmia and is associated with increased
      cardiovascular morbidity and mortality, with stroke being an especially important and
      potentially devastating complication. The number of patients with atrial fibrillation is
      likely to increase 2.5-fold during the next 50 years, reflecting the growing proportion of
      elderly individuals. Emergency departments play a central role in diagnosis and treatment
      (rhythm and rate control, initiation of anticoagulatory therapy for stroke prevention) of
      atrial fibrillation. Additionally, embolic (e.g. stroke, mesenteric ischemia) complications
      of atrial fibrillation and bleeding complications (e.g. gastrointestinal and intracranial) of
      anticoagulatory therapy are likewise treated at emergency departments.

      Therefor the investigators hypothesis implies that the atrial fibrillation registry could
      serve as a tool for structured diagnosis and therapy in patients with atrial fibrillation and
      therefore may improve patient care. Additionally, diagnostic and therapeutic shortcomings by
      analyzing registry data may be detected.
observational model: Cohort
time perspective: Prospective
measure: Number of participants with major adverse cardiac events
time frame: Follow up (10 years)
description: frequency distribution
measure: Number of successfully conducted cardioversions
time frame: Follow up (10 years)
description: frequency distribution
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander Spiel, Priv. Doz.
role: Principal Investigator
affiliation: Medical University Vienna
last name: Jan Niederdöckl, Dr.
email: jan.niederdöckl@meduniwien.ac.at
last name: Alexander Simon, Dr.
email: alexander.simon@meduniwien.ac.at
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
citation: Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.
PMID: 11343485
citation: Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomized controlled trials. Arch Intern Med. 1994 Jul 11;154(13):1449-57. Erratum In: Arch Intern Med 1994 Oct 10;154(19):2254.
PMID: 8018000
citation: Lip GY, Tean KN, Dunn FG. Treatment of atrial fibrillation in a district general hospital. Br Heart J. 1994 Jan;71(1):92-5. doi: 10.1136/hrt.71.1.92.
PMID: 8297706
citation: Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.
PMID: 9737513
citation: O'Reilly DJ, Hopkins RB, Healey JS, Dorian P, Sauriol L, Tarride JE, Burke N, Goeree RA. The burden of atrial fibrillation on the hospital sector in Canada. Can J Cardiol. 2013 Feb;29(2):229-35. doi: 10.1016/j.cjca.2012.03.023. Epub 2012 May 30.
PMID: 22652091
citation: Domanovits H, Schillinger M, Thoennissen J, Nikfardjam M, Janata K, Brunner M, Laggner AN. Termination of recent-onset atrial fibrillation/flutter in the emergency department: a sequential approach with intravenous ibutilide and external electrical cardioversion. Resuscitation. 2000 Aug 1;45(3):181-7. doi: 10.1016/s0300-9572(00)00180-5.
PMID: 10959017
citation: Vinson DR, Hoehn T, Graber DJ, Williams TM. Managing emergency department patients with recent-onset atrial fibrillation. J Emerg Med. 2012 Feb;42(2):139-48. doi: 10.1016/j.jemermed.2010.05.017. Epub 2010 Jul 15.
PMID: 20634022
citation: von Besser K, Mills AM. Is discharge to home after emergency department cardioversion safe for the treatment of recent-onset atrial fibrillation? Ann Emerg Med. 2011 Dec;58(6):517-20. doi: 10.1016/j.annemergmed.2011.06.014. Epub 2011 Jul 29.
PMID: 22098994
citation: Bellone A, Etteri M, Vettorello M, Bonetti C, Clerici D, Gini G, Maino C, Mariani M, Natalizi A, Nessi I, Rampoldi A, Colombo L. Cardioversion of acute atrial fibrillation in the emergency department: a prospective randomised trial. Emerg Med J. 2012 Mar;29(3):188-91. doi: 10.1136/emj.2010.109702. Epub 2011 Mar 21.
PMID: 21422032
citation: Hochtl T, Huber K. New anticoagulants for the prevention of stroke in atrial fibrillation. Fundam Clin Pharmacol. 2012 Feb;26(1):47-53. doi: 10.1111/j.1472-8206.2011.00982.x. Epub 2011 Aug 29.
PMID: 21883447
citation: Oldgren J, Healey JS, Ezekowitz M, Commerford P, Avezum A, Pais P, Zhu J, Jansky P, Sigamani A, Morillo CA, Liu L, Damasceno A, Grinvalds A, Nakamya J, Reilly PA, Keltai K, Van Gelder IC, Yusufali AH, Watanabe E, Wallentin L, Connolly SJ, Yusuf S; RE-LY Atrial Fibrillation Registry Investigators. Variations in cause and management of atrial fibrillation in a prospective registry of 15,400 emergency department patients in 46 countries: the RE-LY Atrial Fibrillation Registry. Circulation. 2014 Apr 15;129(15):1568-76. doi: 10.1161/CIRCULATIONAHA.113.005451. Epub 2014 Jan 24. Erratum In: Circulation. 2015 Feb 17;131(7):e352.
PMID: 24463370
citation: Rovellini A, Folli C, Cardani F, Monzani V. Thromboembolic and haemorrhagic events in permanent atrial fibrillation: observational study in an emergency department. Eur J Intern Med. 2009 Dec;20(8):756-9. doi: 10.1016/j.ejim.2009.08.008. Epub 2009 Sep 24.
PMID: 19892303
citation: Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines-CPG; Document Reviewers. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation--developed with the special contribution of the European Heart Rhythm Association. Europace. 2012 Oct;14(10):1385-413. doi: 10.1093/europace/eus305. Epub 2012 Aug 24. No abstract available.
PMID: 22923145
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Alexander Spiel
investigator title: Associate Professor at the Department of Emergency Medicine
mesh term: Atrial Fibrillation
mesh term: Atrial Flutter
mesh term: Emergencies
sharing ipd: No