<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/NCT01723761</url>
  </required_header>
  <id_info>
    <org_study_id>ARIAPOL 01</org_study_id>
    <nct_id>NCT01723761</nct_id>
  </id_info>
  <brief_title>Correlations Between Arrhythmias and Air Pollution in Patients With Pacemaker and ICD</brief_title>
  <acronym>ARIA</acronym>
  <official_title>Correlations Between Arrhythmias, Climatic Variables and Air Pollution in Patients With Pacemaker and ICD, Followed by Remote Monitoring.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Effect Group, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Effect Group, Italy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is a clinical, observational study to evaluate the correlations among arrhythmias,&#xD;
      climatic variables and air pollution in patients with pacemaker and implantable defibrillator&#xD;
      (ICD), followed by remote monitoring.&#xD;
&#xD;
      Purpose of the Study: The purpose of this study is to test the hypothesis that changes in&#xD;
      climatic variables, such as temperature, pressure and humidity, and changes of particulate&#xD;
      matter &lt;10µ (PM10), particulate matter &lt;2.5µ (PM2.5), ozone (O3), carbon monoxide (CO),&#xD;
      sulfur dioxide (SO2), nitrogen dioxide (NO2), are associated with an increase of&#xD;
      supraventricular and ventricular arrhythmias.&#xD;
&#xD;
      Objectives: The aim of this study is to determine whether changes in variables conditions&#xD;
      affect the electrical stability of the myocardium in patients with pacemakers and ICDs.&#xD;
&#xD;
      Population: male and female subjects, aged ≥ 18 years, implanted by a dual-chamber pacemaker,&#xD;
      ICD or biventricular ICD (ICD-CRT). A total of 500 subjects from 15 cardiology centers of the&#xD;
      Veneto region will be included.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objectives of this study are as follows:&#xD;
&#xD;
        -  Determine if the changes of temperature, pressure and humidity, are associated with an&#xD;
           increase of atrial and ventricular arrhythmias.&#xD;
&#xD;
        -  Determine if the changes of air pollution (gas and particulate), are associated with an&#xD;
           increase of atrial and ventricular arrhythmias.&#xD;
&#xD;
      The secondary objectives of the study are:&#xD;
&#xD;
        -  Determine if the changes of air pollution (gas and particulate), are associated with&#xD;
           significant changes in mean heart rate, rate variability rate and the percentage of&#xD;
           paced beats.&#xD;
&#xD;
        -  Determine whether changes in temperature, pressure or humidity, are associated with&#xD;
           significant changes in mean heart rate, heart rate variability and the percentage of&#xD;
           paced beats.&#xD;
&#xD;
        -  Determine if the changes of temperature, pressure and humidity, are associated with an&#xD;
           increase in mortality or hospitalization for myocardial infarction or congestive heart&#xD;
           failure.&#xD;
&#xD;
        -  Determine if the changes of air pollution (gas and particulate), are associated with an&#xD;
           increase in mortality or hospitalization for myocardial infarction or congestive heart&#xD;
           failure.&#xD;
&#xD;
      Study Design This is a prospective, observational study, which compares the occurrence of&#xD;
      atrial and ventricular arrhythmias and changes in physiological parameters, with climatic&#xD;
      variables and air pollution.&#xD;
&#xD;
      The study will include 500 subjects and will consist of two periods:&#xD;
&#xD;
      Screening: we will collect baseline characteristics of subjects in the clinical examination.&#xD;
      The period recruitment will run for 12 months.&#xD;
&#xD;
      Follow-up: After written informed consent will be signed, subjects who meet the criteria for&#xD;
      inclusion will be enrolled in the study and followed up for a minimum period of 12 months.&#xD;
      The data obtained from the remote monitoring will be evaluated for the daily values provided&#xD;
      for the parameters considered in the study.&#xD;
&#xD;
      Periodical visits in pacemaker clinic will be scheduled at the discretion of the referring&#xD;
      cardiologist of the center. The arrhythmic events that will occur in this period, detected by&#xD;
      means of remote monitoring or through other clinical evaluations will be recorded. Atrial&#xD;
      arrythmias: atrial fibrillation or atrial flutter, supraventricular tachycardia.&#xD;
&#xD;
      Ventricular arrhythmias: ventricular tachycardia, ventricular fibrillation, ventricular&#xD;
      extrasystoles.&#xD;
&#xD;
      Physiological variables: average heart rate (24 hours and at rest), heart rate variability,&#xD;
      the percentage of paced beats.&#xD;
&#xD;
      In addition, any changes in drug therapies and all clinically relevant events, will be&#xD;
      recorded.&#xD;
&#xD;
      During the same period data from monitoring stations of ARPAV (Regional Agency for&#xD;
      Environmental Prevention and Protection of Veneto Region) will be collected.&#xD;
&#xD;
      Climatic variables: temperature, humidity, atmospheric pressure. Parameters of air pollution:&#xD;
      PM10, PM2.5, O3, CO, SO2, NO2. For each patient, the data from the monitoring station ARPAV&#xD;
      of the urban area of residence of the subject will be considered. The mean exposure level&#xD;
      used in the analytical studies on the health effects is calculated on the average number of&#xD;
      units active in the area. This number is usually of 2-3 units in large centers, while it is&#xD;
      generally only 1 in small towns. The residents in centers without monitoring will be excluded&#xD;
      from the study. The mean value is the best approximation ... to be continued page 6.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">November 2013</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>incidence of atrial arrhythmias.</measure>
    <time_frame>12- 24 months.</time_frame>
    <description>The arrhythmic events that will occur during follow-up period, detected by remote monitoring or through other clinical evaluations, will be recorded and classified as follows: atrial fibrillation or atrial flutter, supraventricular tachycardia.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of ventricular arrhythmias</measure>
    <time_frame>12-24 months</time_frame>
    <description>The arrhythmic events that will occur during follow-up period, detected by remote monitoring or through other clinical evaluations, will be recorded and classified as follows: ventricular tachycardia, ventricular fibrillation, premature ventricular beats.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean heart rate</measure>
    <time_frame>12-24 months</time_frame>
    <description>Mean heart rate obtained by remote monitoring of pacemaker and ICDs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>12-24 months</time_frame>
    <description>Measures of heart rate variability calculated by devices and obtained by remote monitoring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of paced beats</measure>
    <time_frame>12-24 months</time_frame>
    <description>Percentage of paced beats will be measured by devices diagnostic and obtained via remote monitoring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality for myocardial infarction or heart failure.</measure>
    <time_frame>12-24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization for myocardial infarction or heart failure.</measure>
    <time_frame>12-24 months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">473</enrollment>
  <condition>Cardiac Arrhythmias</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Males and females, aged ≥ 18 years of age who have been implanted with a dual-chamber&#xD;
        pacemaker, an ICD or ICD-CRT.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable subjects,&gt; 18 years, who have been implanted with a dual-chamber pacemaker, an&#xD;
             ICD or ICD-CRT, compatible with remote monitoring systems, with daily transmission of&#xD;
             data.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of heart failure clinically manifest.&#xD;
&#xD;
          -  Concomitant illness or a significant condition which severely limits the life&#xD;
             expectancy.&#xD;
&#xD;
          -  Any medical or surgical condition that, at the discretion of the investigator, places&#xD;
             the patient at higher risk for his participation in the study.&#xD;
&#xD;
          -  History of malignancy of any organ system in the last two years, whether treated or&#xD;
             untreated, including leukemia and lymphoma (with the exception of basal cell carcinoma&#xD;
             of the skin) if there is evidence of local recurrence of metastasis.&#xD;
&#xD;
          -  History of drug or alcohol abuse in the last 2 years.&#xD;
&#xD;
          -  Participation in another study of a drug or device within 30 days after randomization.&#xD;
&#xD;
          -  Inability to communicate and to comply with all such obligations including the&#xD;
             unwillingness or inability to give an informed consent.&#xD;
&#xD;
          -  Residence in urban centers without environmental monitoring.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gianfranco Buja, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Padova</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ospedale S.Maria dei Battuti - Cardiologia</name>
      <address>
        <city>Conegliano</city>
        <zip>31015</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale di ESte</name>
      <address>
        <city>Este</city>
        <zip>35042</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mater Salutis</name>
      <address>
        <city>Legnago</city>
        <zip>37045</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dell'Angelo Hospital</name>
      <address>
        <city>Mestre</city>
        <zip>30175</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Civile</name>
      <address>
        <city>Mirano</city>
        <zip>30039</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Valentino</name>
      <address>
        <city>Montebelluna</city>
        <zip>31044</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Civic Hospital</name>
      <address>
        <city>Portogruaro</city>
        <zip>30026</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Ca' Foncello - Divisione di Cardiologia</name>
      <address>
        <city>Treviso</city>
        <zip>31100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>July 1, 2015</last_update_submitted>
  <last_update_submitted_qc>July 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>air pollution</keyword>
  <keyword>pacemaker</keyword>
  <keyword>ICD</keyword>
  <keyword>remote monitoring</keyword>
  <keyword>supraventricular arrhythmias</keyword>
  <keyword>ventricular arrhythmias</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</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/NCT01723761
org study id: ARIAPOL 01
nct id: NCT01723761
lead sponsor: 
has dmc: No
It is a clinical, observational study to evaluate the correlations among arrhythmias,
      climatic variables and air pollution in patients with pacemaker and implantable defibrillator
      (ICD), followed by remote monitoring.

      Purpose of the Study: The purpose of this study is to test the hypothesis that changes in
      climatic variables, such as temperature, pressure and humidity, and changes of particulate
      matter <10µ (PM10), particulate matter <2.5µ (PM2.5), ozone (O3), carbon monoxide (CO),
      sulfur dioxide (SO2), nitrogen dioxide (NO2), are associated with an increase of
      supraventricular and ventricular arrhythmias.

      Objectives: The aim of this study is to determine whether changes in variables conditions
      affect the electrical stability of the myocardium in patients with pacemakers and ICDs.

      Population: male and female subjects, aged ≥ 18 years, implanted by a dual-chamber pacemaker,
      ICD or biventricular ICD (ICD-CRT). A total of 500 subjects from 15 cardiology centers of the
      Veneto region will be included.
The primary objectives of this study are as follows:

        -  Determine if the changes of temperature, pressure and humidity, are associated with an
           increase of atrial and ventricular arrhythmias.

        -  Determine if the changes of air pollution (gas and particulate), are associated with an
           increase of atrial and ventricular arrhythmias.

      The secondary objectives of the study are:

        -  Determine if the changes of air pollution (gas and particulate), are associated with
           significant changes in mean heart rate, rate variability rate and the percentage of
           paced beats.

        -  Determine whether changes in temperature, pressure or humidity, are associated with
           significant changes in mean heart rate, heart rate variability and the percentage of
           paced beats.

        -  Determine if the changes of temperature, pressure and humidity, are associated with an
           increase in mortality or hospitalization for myocardial infarction or congestive heart
           failure.

        -  Determine if the changes of air pollution (gas and particulate), are associated with an
           increase in mortality or hospitalization for myocardial infarction or congestive heart
           failure.

      Study Design This is a prospective, observational study, which compares the occurrence of
      atrial and ventricular arrhythmias and changes in physiological parameters, with climatic
      variables and air pollution.

      The study will include 500 subjects and will consist of two periods:

      Screening: we will collect baseline characteristics of subjects in the clinical examination.
      The period recruitment will run for 12 months.

      Follow-up: After written informed consent will be signed, subjects who meet the criteria for
      inclusion will be enrolled in the study and followed up for a minimum period of 12 months.
      The data obtained from the remote monitoring will be evaluated for the daily values provided
      for the parameters considered in the study.

      Periodical visits in pacemaker clinic will be scheduled at the discretion of the referring
      cardiologist of the center. The arrhythmic events that will occur in this period, detected by
      means of remote monitoring or through other clinical evaluations will be recorded. Atrial
      arrythmias: atrial fibrillation or atrial flutter, supraventricular tachycardia.

      Ventricular arrhythmias: ventricular tachycardia, ventricular fibrillation, ventricular
      extrasystoles.

      Physiological variables: average heart rate (24 hours and at rest), heart rate variability,
      the percentage of paced beats.

      In addition, any changes in drug therapies and all clinically relevant events, will be
      recorded.

      During the same period data from monitoring stations of ARPAV (Regional Agency for
      Environmental Prevention and Protection of Veneto Region) will be collected.

      Climatic variables: temperature, humidity, atmospheric pressure. Parameters of air pollution:
      PM10, PM2.5, O3, CO, SO2, NO2. For each patient, the data from the monitoring station ARPAV
      of the urban area of residence of the subject will be considered. The mean exposure level
      used in the analytical studies on the health effects is calculated on the average number of
      units active in the area. This number is usually of 2-3 units in large centers, while it is
      generally only 1 in small towns. The residents in centers without monitoring will be excluded
      from the study. The mean value is the best approximation ... to be continued page 6.
observational model: Cohort
time perspective: Prospective
measure: incidence of atrial arrhythmias.
time frame: 12- 24 months.
description: The arrhythmic events that will occur during follow-up period, detected by remote monitoring or through other clinical evaluations, will be recorded and classified as follows: atrial fibrillation or atrial flutter, supraventricular tachycardia.
measure: incidence of ventricular arrhythmias
time frame: 12-24 months
description: The arrhythmic events that will occur during follow-up period, detected by remote monitoring or through other clinical evaluations, will be recorded and classified as follows: ventricular tachycardia, ventricular fibrillation, premature ventricular beats.
measure: Mean heart rate
time frame: 12-24 months
description: Mean heart rate obtained by remote monitoring of pacemaker and ICDs.
measure: Heart rate variability
time frame: 12-24 months
description: Measures of heart rate variability calculated by devices and obtained by remote monitoring.
measure: Percentage of paced beats
time frame: 12-24 months
description: Percentage of paced beats will be measured by devices diagnostic and obtained via remote monitoring.
measure: Mortality for myocardial infarction or heart failure.
time frame: 12-24 months
measure: Hospitalization for myocardial infarction or heart failure.
time frame: 12-24 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Gianfranco Buja, MD
role: Principal Investigator
affiliation: University of Padova
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac