<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/NCT03301662</url>
  </required_header>
  <id_info>
    <org_study_id>2017321</org_study_id>
    <nct_id>NCT03301662</nct_id>
  </id_info>
  <brief_title>Transient Electrocardiogram Assessment in Stroke Evaluation</brief_title>
  <acronym>TEASE</acronym>
  <official_title>Transient Electrocardiogram Assessment in Stroke Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Gävleborg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Gävleborg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In stroke survivors, atrial fibrillation is typically detected with short-term&#xD;
      electrocardiogram (ECG) monitoring in the stroke unit. Prolonged continuous ECG monitoring is&#xD;
      impractical and requires substantial resources while insertable cardiac monitors are invasive&#xD;
      and costly. Chest and thumb-ECG could provide an alternative for atrial fibrillation&#xD;
      detection post-stroke.&#xD;
&#xD;
      The primary objective of our study is to assess the incidence of newly diagnosed atrial&#xD;
      fibrillation during 28 days of chest and thumb-ECG monitoring in patients with cryptogenic&#xD;
      stroke. Secondary objectives are to assess Health-related Quality of Life using Short Form-36&#xD;
      and the feasibility of the Coala Heart Monitor in patients with stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke survivors in Region Gävleborg, Sweden, will be eligible for the study from October&#xD;
      2017. Patients with a history of ischemic stroke without documented atrial fibrillation&#xD;
      before or during ECG evaluation in the stroke unit will be evaluated by the chest and&#xD;
      thumb-ECG system Coala Heart Monitor. The monitoring system is connected to a smart phone&#xD;
      application which allows for remote monitoring and prompt advice on clinical management. Over&#xD;
      a period of 28 days, patients will be monitored twice daily and may activate the ECG&#xD;
      recording at symptoms. Upon completion, the system is returned by mail. This system offers a&#xD;
      possibility to evaluate the presence of atrial fibrillation post-stroke, but the feasibility&#xD;
      of this system in patients who recently suffered from a stroke is unknown. In addition&#xD;
      Health-related Quality of Life using Short Form-36 in comparison to Swedish population norms&#xD;
      will be assessed. The feasibility of the Coala Heart Monitor will be assessed by a&#xD;
      self-developed questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 9, 2017</start_date>
  <completion_date type="Anticipated">October 9, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 9, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative incidence of atrial arrhythmia</measure>
    <time_frame>28 days (prospectively)</time_frame>
    <description>Cumulative incidence of atrial arrhythmia at 28 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Previous atrial arrhythmia</measure>
    <time_frame>10 years (retrospectively)</time_frame>
    <description>The prevalence of previously known atrial arrhythmia before cryptogenic stroke and the number of these patients who had anticoagulant therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance with chest and thumb-ECG</measure>
    <time_frame>28 days (prospectively)</time_frame>
    <description>Compliance with chest and thumb-ECG at week four (number of recorded scheduled ECG tracings).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported experience with chest and thumb-ECG</measure>
    <time_frame>6 weeks (prospectively)</time_frame>
    <description>Patient-reported experience with chest and thumb-ECG measured at week six</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality of Life</measure>
    <time_frame>12 months prospectively</time_frame>
    <description>Health-related Quality of Life (Short Form-36) at week 6 and at 12 months and the association with atrial fibrillation and compliance with chest and thumb-ECG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of stroke</measure>
    <time_frame>3 years prospectively</time_frame>
    <description>Cumulative incidence of stroke (and all-cause mortality) after three years in patients with atrial fibrillation versus without atrial fibrillation.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Stroke</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>chest and thumb- ECG</intervention_name>
    <description>chest and thumb- ECG using the Coala Heart Monitor</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a clinically confirmed diagnosis of ischemic stroke will be recruited from&#xD;
        the catchment area of Region Gävleborg, Sweden. Eligible patients will be identified from&#xD;
        daily checks of the medical records in the stroke unit. The recruitment is planned to start&#xD;
        in October 2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients, aged ≥18 years, with a validated diagnosis of ischemic cryptogenic stroke&#xD;
             are eligible for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For screening with chest and thumb-ECG, exclusion criteria are as follows: previously&#xD;
             known atrial arrhythmia with an indication for anticoagulation, implantable&#xD;
             defibrillator, pacemaker or insertable cardiac monitor, pregnancy, permanent&#xD;
             indication for anticoagulation (including low-molecular weight heparin) due to atrial&#xD;
             arrhythmia, mechanical heart valve, deep vein thrombosis, or pulmonary embolism.&#xD;
             Patients with a life expectancy ≤6 months (e.g. severe heart failure New York Heart&#xD;
             Association functional class IV or malignancy) are likewise excluded.&#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>Hirsh M Koyi, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uppsala University/Region Gävleborg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peter M Magnusson, MD</last_name>
    <phone>0705089407</phone>
    <phone_ext>+46</phone_ext>
    <email>peter.magnusson@regiongavleborg.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gustav Mattsson, MD</last_name>
    <phone>0703122296</phone>
    <phone_ext>+46</phone_ext>
    <email>gustav.mattsson@regiongavleborg.se</email>
  </overall_contact_backup>
  <results_reference>
    <citation>Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007.</citation>
    <PMID>17577005</PMID>
  </results_reference>
  <results_reference>
    <citation>Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014 Mar 15;383(9921):955-62. doi: 10.1016/S0140-6736(13)62343-0. Epub 2013 Dec 4.</citation>
    <PMID>24315724</PMID>
  </results_reference>
  <results_reference>
    <citation>Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1. Erratum In: Stroke. 2015 Feb;46(2):e54.</citation>
    <PMID>24788967</PMID>
  </results_reference>
  <results_reference>
    <citation>Sjalander S, Sjalander A, Svensson PJ, Friberg L. Atrial fibrillation patients do not benefit from acetylsalicylic acid. Europace. 2014 May;16(5):631-8. doi: 10.1093/europace/eut333. Epub 2013 Oct 24.</citation>
    <PMID>24158253</PMID>
  </results_reference>
  <results_reference>
    <citation>Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P, Agewall S, Camm J, Baron Esquivias G, Budts W, Carerj S, Casselman F, Coca A, De Caterina R, Deftereos S, Dobrev D, Ferro JM, Filippatos G, Fitzsimons D, Gorenek B, Guenoun M, Hohnloser SH, Kolh P, Lip GY, Manolis A, McMurray J, Ponikowski P, Rosenhek R, Ruschitzka F, Savelieva I, Sharma S, Suwalski P, Tamargo JL, Taylor CJ, Van Gelder IC, Voors AA, Windecker S, Zamorano JL, Zeppenfeld K. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. 2016 Nov;18(11):1609-1678. doi: 10.1093/europace/euw295. Epub 2016 Aug 27. No abstract available.</citation>
    <PMID>27567465</PMID>
  </results_reference>
  <results_reference>
    <citation>Schnabel RB, Yin X, Gona P, Larson MG, Beiser AS, McManus DD, Newton-Cheh C, Lubitz SA, Magnani JW, Ellinor PT, Seshadri S, Wolf PA, Vasan RS, Benjamin EJ, Levy D. 50 year trends in atrial fibrillation prevalence, incidence, risk factors, and mortality in the Framingham Heart Study: a cohort study. Lancet. 2015 Jul 11;386(9989):154-62. doi: 10.1016/S0140-6736(14)61774-8. Epub 2015 May 7.</citation>
    <PMID>25960110</PMID>
  </results_reference>
  <results_reference>
    <citation>Andersson T, Magnuson A, Bryngelsson IL, Frobert O, Henriksson KM, Edvardsson N, Poci D. All-cause mortality in 272,186 patients hospitalized with incident atrial fibrillation 1995-2008: a Swedish nationwide long-term case-control study. Eur Heart J. 2013 Apr;34(14):1061-7. doi: 10.1093/eurheartj/ehs469. Epub 2013 Jan 14.</citation>
    <PMID>23321349</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>cryptogenic stroke</keyword>
  <keyword>ECG screening</keyword>
  <keyword>health-related quality of life</keyword>
  <keyword>Short Form-36</keyword>
  <keyword>stroke</keyword>
  <keyword>thumb-ECG</keyword>
  <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>
  <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/NCT03301662
org study id: 2017321
nct id: NCT03301662
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In stroke survivors, atrial fibrillation is typically detected with short-term
      electrocardiogram (ECG) monitoring in the stroke unit. Prolonged continuous ECG monitoring is
      impractical and requires substantial resources while insertable cardiac monitors are invasive
      and costly. Chest and thumb-ECG could provide an alternative for atrial fibrillation
      detection post-stroke.

      The primary objective of our study is to assess the incidence of newly diagnosed atrial
      fibrillation during 28 days of chest and thumb-ECG monitoring in patients with cryptogenic
      stroke. Secondary objectives are to assess Health-related Quality of Life using Short Form-36
      and the feasibility of the Coala Heart Monitor in patients with stroke.
Stroke survivors in Region Gävleborg, Sweden, will be eligible for the study from October
      2017. Patients with a history of ischemic stroke without documented atrial fibrillation
      before or during ECG evaluation in the stroke unit will be evaluated by the chest and
      thumb-ECG system Coala Heart Monitor. The monitoring system is connected to a smart phone
      application which allows for remote monitoring and prompt advice on clinical management. Over
      a period of 28 days, patients will be monitored twice daily and may activate the ECG
      recording at symptoms. Upon completion, the system is returned by mail. This system offers a
      possibility to evaluate the presence of atrial fibrillation post-stroke, but the feasibility
      of this system in patients who recently suffered from a stroke is unknown. In addition
      Health-related Quality of Life using Short Form-36 in comparison to Swedish population norms
      will be assessed. The feasibility of the Coala Heart Monitor will be assessed by a
      self-developed questionnaire.
observational model: Cohort
time perspective: Prospective
measure: Cumulative incidence of atrial arrhythmia
time frame: 28 days (prospectively)
description: Cumulative incidence of atrial arrhythmia at 28 days.
measure: Previous atrial arrhythmia
time frame: 10 years (retrospectively)
description: The prevalence of previously known atrial arrhythmia before cryptogenic stroke and the number of these patients who had anticoagulant therapy.
measure: Compliance with chest and thumb-ECG
time frame: 28 days (prospectively)
description: Compliance with chest and thumb-ECG at week four (number of recorded scheduled ECG tracings).
measure: Patient-reported experience with chest and thumb-ECG
time frame: 6 weeks (prospectively)
description: Patient-reported experience with chest and thumb-ECG measured at week six
measure: Health-related Quality of Life
time frame: 12 months prospectively
description: Health-related Quality of Life (Short Form-36) at week 6 and at 12 months and the association with atrial fibrillation and compliance with chest and thumb-ECG.
measure: Cumulative incidence of stroke
time frame: 3 years prospectively
description: Cumulative incidence of stroke (and all-cause mortality) after three years in patients with atrial fibrillation versus without atrial fibrillation.
intervention type: Diagnostic Test
intervention name: chest and thumb- ECG
description: chest and thumb- ECG using the Coala Heart Monitor
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hirsh M Koyi, MD PhD
role: Principal Investigator
affiliation: Uppsala University/Region Gävleborg
last name: Peter M Magnusson, MD
phone: 0705089407
phone ext: +46
email: peter.magnusson@regiongavleborg.se
last name: Gustav Mattsson, MD
phone: 0703122296
phone ext: +46
email: gustav.mattsson@regiongavleborg.se
citation: Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007.
PMID: 17577005
citation: Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014 Mar 15;383(9921):955-62. doi: 10.1016/S0140-6736(13)62343-0. Epub 2013 Dec 4.
PMID: 24315724
citation: Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1. Erratum In: Stroke. 2015 Feb;46(2):e54.
PMID: 24788967
citation: Sjalander S, Sjalander A, Svensson PJ, Friberg L. Atrial fibrillation patients do not benefit from acetylsalicylic acid. Europace. 2014 May;16(5):631-8. doi: 10.1093/europace/eut333. Epub 2013 Oct 24.
PMID: 24158253
citation: Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P, Agewall S, Camm J, Baron Esquivias G, Budts W, Carerj S, Casselman F, Coca A, De Caterina R, Deftereos S, Dobrev D, Ferro JM, Filippatos G, Fitzsimons D, Gorenek B, Guenoun M, Hohnloser SH, Kolh P, Lip GY, Manolis A, McMurray J, Ponikowski P, Rosenhek R, Ruschitzka F, Savelieva I, Sharma S, Suwalski P, Tamargo JL, Taylor CJ, Van Gelder IC, Voors AA, Windecker S, Zamorano JL, Zeppenfeld K. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. 2016 Nov;18(11):1609-1678. doi: 10.1093/europace/euw295. Epub 2016 Aug 27. No abstract available.
PMID: 27567465
citation: Schnabel RB, Yin X, Gona P, Larson MG, Beiser AS, McManus DD, Newton-Cheh C, Lubitz SA, Magnani JW, Ellinor PT, Seshadri S, Wolf PA, Vasan RS, Benjamin EJ, Levy D. 50 year trends in atrial fibrillation prevalence, incidence, risk factors, and mortality in the Framingham Heart Study: a cohort study. Lancet. 2015 Jul 11;386(9989):154-62. doi: 10.1016/S0140-6736(14)61774-8. Epub 2015 May 7.
PMID: 25960110
citation: Andersson T, Magnuson A, Bryngelsson IL, Frobert O, Henriksson KM, Edvardsson N, Poci D. All-cause mortality in 272,186 patients hospitalized with incident atrial fibrillation 1995-2008: a Swedish nationwide long-term case-control study. Eur Heart J. 2013 Apr;34(14):1061-7. doi: 10.1093/eurheartj/ehs469. Epub 2013 Jan 14.
PMID: 23321349
responsible party type: Sponsor
mesh term: Stroke
mesh term: Atrial Fibrillation
sharing ipd: No