<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/NCT03231826</url>
  </required_header>
  <id_info>
    <org_study_id>R17023</org_study_id>
    <nct_id>NCT03231826</nct_id>
  </id_info>
  <brief_title>Arrhythmias in Post-Myocardial Infarction Patients</brief_title>
  <official_title>Exploring Arrhythmias After Hospital Discharge in Post-Myocardial Infarction Patients - the MADDEC Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tampere University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tays Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>GE Healthcare Finland Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fimlab Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>VTT Technical Research Centre of Finland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bittium Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tekes - Finnish Funding Agency for Innovation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Politecnico Milano</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tampere University</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>
      Patients are screened for significant arrhythmias and other possibly significant ECG-patterns&#xD;
      directly after discharge and two weeks after myocardial infarction using wearable devices.&#xD;
      The home monitoring data will be linked with extensive data from electronic health records&#xD;
      collected before, during hospital stay and after discharge.&#xD;
&#xD;
      The purpose of the study is to clarify whether home monitoring of continuous ECG-signals can&#xD;
      be used to predict and prevent serious adverse events after myocardial infarction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with acute myocardial infarction have exceptionally high mortality rates exceeding&#xD;
      10% during the first year post-MI. The incidence of sudden cardiac death after acute&#xD;
      myocardial infarction is the same with ST-elevation and non-ST elevation myocardial&#xD;
      infarction. The risk of disabling stroke and sudden cardiac death is high especially during&#xD;
      the first months after myocardial infarction. Preventing these outcomes is of high priority,&#xD;
      considering the fact that the quality of life can remain high in these patients, if serious&#xD;
      adverse events can be avoided.&#xD;
&#xD;
      The high mortality and comorbidity rates among cardiac patients provide an opportunistic&#xD;
      environment for testing the utility of of home monitoring by mobile devices, data integration&#xD;
      and resulting mass data. Long follow-up times are not required, which facilitates the linking&#xD;
      of potential risk factors with outcome.&#xD;
&#xD;
      The prospective part of the MADDEC (MAss Data in Detection and prevention of serious adverse&#xD;
      Events in Cardiovascular disease) project aims at exploring mechanism of sudden death in the&#xD;
      first month after a myocardial infarction and at detecting arrhythmias heralding&#xD;
      life-threatening arrhythmias. Additionally, the project will define the incidence of new&#xD;
      atrial fibrillation post myocardial infarction. The main outcomes of the study are all cause&#xD;
      mortality, cardiovascular mortality, rehospitalization due to any or cardiovascular causes.&#xD;
&#xD;
      Prospective home monitoring of patients after ST-elevation or non-ST elevation myocardial&#xD;
      infarction will commence in May 2017 and continue until the end of 2019. For arrhythmia&#xD;
      detection, two different methods will be used: 12-channel Holter recording (GE Seer 12®, GE&#xD;
      Healthcare Finland) and the eMotion Faros® device (Bittium Biosignals Ltd/Mega Elec-troncs&#xD;
      Ltd, Finland). The aim is to record continuous 12-channel Holter data from 200-250 patients&#xD;
      with ST-elevation myo-cardial infarction and 1-3 channel ECG signal data with the mobile&#xD;
      Faros 360 device from 550-600 patients with any type of myocardial infarction. Exclusion&#xD;
      criteria are short life expectancy, unwillingness to participate and need for permanent&#xD;
      insti-tutional care. The first 24-48 hour recording will commence at hospital discharge or&#xD;
      transferral to another health care unit. The second recording will take place two weeks after&#xD;
      the index event. As a part of the protocol, the subjects will also perform simple tests&#xD;
      measuring their functional status and possible disability at study enrollment. All accrued&#xD;
      ECG-data will be inte-grated into a research database for further analysis, linking it with&#xD;
      outcome data. The Faros 360 mobile device will also ena-ble recording patient activity, such&#xD;
      as movement and respiratory rate, simultaneously using an accelerometer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2017</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</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>Cardiovascular mortality</measure>
    <time_frame>One month and one year and five after myocardial infarction</time_frame>
    <description>Mortality due to heart failure, complication of myocardial infarction, recurrent myocardial infarction, stroke or probable cardiac arrhythmia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incident asymptomatic atrial fibrillation</measure>
    <time_frame>Within two weeks after myocardial infarction</time_frame>
    <description>Incidence of new-onset atrial fibrillation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incident ventricular arrhythmias</measure>
    <time_frame>Within two weeks after myocardial infarction</time_frame>
    <description>Ventricular tachycardias (NSVT and longer), ventricular fibrillation and Ventricular extrasystoles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incident bradyarrhytmias</measure>
    <time_frame>Within two weeks after myocardial infarction</time_frame>
    <description>New bradyarrhytmias including AV block and sinus arrests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rehospitalization</measure>
    <time_frame>One month and one year and five after myocardial infarction</time_frame>
    <description>Rehospitalization due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rehospitalization (CVD)</measure>
    <time_frame>One month and one year and five after myocardial infarction</time_frame>
    <description>Rehospitalization due cardiovascular cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of symptomatic atrial arrhythmias</measure>
    <time_frame>One month and one year and five after myocardial infarction</time_frame>
    <description>Atrial fibrillation, atrial flutter and other atrial arrhythmias leading to patient seeking medical attention and treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of symptomatic ventricular arrhythmias</measure>
    <time_frame>One month and one year and five after myocardial infarction</time_frame>
    <description>Ventricular fibrillation, ventricular tachycardias and other ventricular arrhythmias medical</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall mortality</measure>
    <time_frame>One month and one year and five after myocardial infarction</time_frame>
    <description>Mortality due to any cause</description>
  </secondary_outcome>
  <enrollment type="Actual">445</enrollment>
  <condition>Myocardial Infarction</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Arrythmia</condition>
  <condition>ECG Electrical Alternans</condition>
  <condition>Atrioventricular Block</condition>
  <condition>Atrial Fibrillation</condition>
  <condition>Atrial Flutter</condition>
  <condition>Ventricular Tachycardia</condition>
  <condition>Ventricular Fibrillation</condition>
  <condition>Ventricular Arrythmia</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Recording of continuous ECG-signals&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients treated at the study center (Tays Heart Hospital) between June 2017 and June&#xD;
        2019 fulfilling the eligibility criteria are invited to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Patients treated for myocardial infarction (NSTEMI and STEMI)&#xD;
&#xD;
        Exclusion Criteria: Short life expectancy, unwillingness to participate and need for&#xD;
        permanent institutional care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jussi A Hernesniemi, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tays Heart Hospital and Tampere University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tays Heart Hospital</name>
      <address>
        <city>Tampere</city>
        <state>Pirkanmaa</state>
        <zip>33540</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <link>
    <url>https://www.springerprofessional.de/en/cohort-description-for-maddec-mass-data-in-detection-and-prevent/12357640</url>
    <description>Cohort description for MADDEC consortia study plan</description>
  </link>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tampere University</investigator_affiliation>
    <investigator_full_name>Jussi Hernesniemi</investigator_full_name>
    <investigator_title>Adjunct Professor</investigator_title>
  </responsible_party>
  <keyword>Home monitoring</keyword>
  <keyword>ECG</keyword>
  <keyword>Myocardial Infarction</keyword>
  <keyword>Arrythmia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Ventricular</mesh_term>
    <mesh_term>Atrial Flutter</mesh_term>
    <mesh_term>Ventricular Fibrillation</mesh_term>
    <mesh_term>Atrioventricular Block</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The use of the collected data is primarily only available to the members of the research consortia but may be made available for collaborators with restrictions and only fully anonymized and pending the approval from the owners of the data</ipd_description>
  </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/NCT03231826
org study id: R17023
nct id: NCT03231826
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients are screened for significant arrhythmias and other possibly significant ECG-patterns
      directly after discharge and two weeks after myocardial infarction using wearable devices.
      The home monitoring data will be linked with extensive data from electronic health records
      collected before, during hospital stay and after discharge.

      The purpose of the study is to clarify whether home monitoring of continuous ECG-signals can
      be used to predict and prevent serious adverse events after myocardial infarction.
Patients with acute myocardial infarction have exceptionally high mortality rates exceeding
      10% during the first year post-MI. The incidence of sudden cardiac death after acute
      myocardial infarction is the same with ST-elevation and non-ST elevation myocardial
      infarction. The risk of disabling stroke and sudden cardiac death is high especially during
      the first months after myocardial infarction. Preventing these outcomes is of high priority,
      considering the fact that the quality of life can remain high in these patients, if serious
      adverse events can be avoided.

      The high mortality and comorbidity rates among cardiac patients provide an opportunistic
      environment for testing the utility of of home monitoring by mobile devices, data integration
      and resulting mass data. Long follow-up times are not required, which facilitates the linking
      of potential risk factors with outcome.

      The prospective part of the MADDEC (MAss Data in Detection and prevention of serious adverse
      Events in Cardiovascular disease) project aims at exploring mechanism of sudden death in the
      first month after a myocardial infarction and at detecting arrhythmias heralding
      life-threatening arrhythmias. Additionally, the project will define the incidence of new
      atrial fibrillation post myocardial infarction. The main outcomes of the study are all cause
      mortality, cardiovascular mortality, rehospitalization due to any or cardiovascular causes.

      Prospective home monitoring of patients after ST-elevation or non-ST elevation myocardial
      infarction will commence in May 2017 and continue until the end of 2019. For arrhythmia
      detection, two different methods will be used: 12-channel Holter recording (GE Seer 12®, GE
      Healthcare Finland) and the eMotion Faros® device (Bittium Biosignals Ltd/Mega Elec-troncs
      Ltd, Finland). The aim is to record continuous 12-channel Holter data from 200-250 patients
      with ST-elevation myo-cardial infarction and 1-3 channel ECG signal data with the mobile
      Faros 360 device from 550-600 patients with any type of myocardial infarction. Exclusion
      criteria are short life expectancy, unwillingness to participate and need for permanent
      insti-tutional care. The first 24-48 hour recording will commence at hospital discharge or
      transferral to another health care unit. The second recording will take place two weeks after
      the index event. As a part of the protocol, the subjects will also perform simple tests
      measuring their functional status and possible disability at study enrollment. All accrued
      ECG-data will be inte-grated into a research database for further analysis, linking it with
      outcome data. The Faros 360 mobile device will also ena-ble recording patient activity, such
      as movement and respiratory rate, simultaneously using an accelerometer.
observational model: Cohort
time perspective: Prospective
measure: Cardiovascular mortality
time frame: One month and one year and five after myocardial infarction
description: Mortality due to heart failure, complication of myocardial infarction, recurrent myocardial infarction, stroke or probable cardiac arrhythmia
measure: Incident asymptomatic atrial fibrillation
time frame: Within two weeks after myocardial infarction
description: Incidence of new-onset atrial fibrillation
measure: Incident ventricular arrhythmias
time frame: Within two weeks after myocardial infarction
description: Ventricular tachycardias (NSVT and longer), ventricular fibrillation and Ventricular extrasystoles.
measure: Incident bradyarrhytmias
time frame: Within two weeks after myocardial infarction
description: New bradyarrhytmias including AV block and sinus arrests.
measure: Rehospitalization
time frame: One month and one year and five after myocardial infarction
description: Rehospitalization due to any cause
measure: Rehospitalization (CVD)
time frame: One month and one year and five after myocardial infarction
description: Rehospitalization due cardiovascular cause
measure: Incidence of symptomatic atrial arrhythmias
time frame: One month and one year and five after myocardial infarction
description: Atrial fibrillation, atrial flutter and other atrial arrhythmias leading to patient seeking medical attention and treatment
measure: Incidence of symptomatic ventricular arrhythmias
time frame: One month and one year and five after myocardial infarction
description: Ventricular fibrillation, ventricular tachycardias and other ventricular arrhythmias medical
measure: Overall mortality
time frame: One month and one year and five after myocardial infarction
description: Mortality due to any cause
Recording of continuous ECG-signals
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jussi A Hernesniemi, MD PhD
role: Principal Investigator
affiliation: Tays Heart Hospital and Tampere University
facility: 
country: Finland
url: https://www.springerprofessional.de/en/cohort-description-for-maddec-mass-data-in-detection-and-prevent/12357640
description: Cohort description for MADDEC consortia study plan
responsible party type: Principal Investigator
investigator affiliation: Tampere University
investigator full name: Jussi Hernesniemi
investigator title: Adjunct Professor
mesh term: Atrial Fibrillation
mesh term: Coronary Artery Disease
mesh term: Myocardial Infarction
mesh term: Arrhythmias, Cardiac
mesh term: Tachycardia
mesh term: Tachycardia, Ventricular
mesh term: Atrial Flutter
mesh term: Ventricular Fibrillation
mesh term: Atrioventricular Block
mesh term: Infarction
sharing ipd: Undecided
ipd description: The use of the collected data is primarily only available to the members of the research consortia but may be made available for collaborators with restrictions and only fully anonymized and pending the approval from the owners of the data