Correlations Between Arrhythmias and Air Pollution in Patients With Pacemaker and ICD (ARIA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Effect Group, Italy
ClinicalTrials.gov Identifier:
NCT01723761
First received: October 23, 2012
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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.


Condition
Air Pollution

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlations Between Arrhythmias, Climatic Variables and Air Pollution in Patients With Pacemaker and ICD, Followed by Remote Monitoring.

Resource links provided by NLM:


Further study details as provided by Effect Group, Italy:

Primary Outcome Measures:
  • incidence of atrial arrhythmias. [ Time Frame: 12- 24 months. ] [ Designated as safety issue: No ]
    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.

  • incidence of ventricular arrhythmias [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean heart rate [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]
    Mean heart rate obtained by remote monitoring of pacemaker and ICDs.

  • Heart rate variability [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]
    Measures of heart rate variability calculated by devices and obtained by remote monitoring.

  • Percentage of paced beats [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]
    Percentage of paced beats will be measured by devices diagnostic and obtained via remote monitoring.

  • Mortality for myocardial infarction or heart failure. [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]
  • Hospitalization for myocardial infarction or heart failure. [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]

Enrollment: 483
Study Start Date: April 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Males and females, aged ≥ 18 years of age who have been implanted with a dual-chamber pacemaker, an ICD or ICD-CRT.

Criteria

Inclusion Criteria:

  • Stable subjects,> 18 years, who have been implanted with a dual-chamber pacemaker, an ICD or ICD-CRT, compatible with remote monitoring systems, with daily transmission of data.

Exclusion Criteria:

  • Presence of heart failure clinically manifest.
  • Concomitant illness or a significant condition which severely limits the life expectancy.
  • Any medical or surgical condition that, at the discretion of the investigator, places the patient at higher risk for his participation in the study.
  • History of malignancy of any organ system in the last two years, whether treated or untreated, including leukemia and lymphoma (with the exception of basal cell carcinoma of the skin) if there is evidence of local recurrence of metastasis.
  • History of drug or alcohol abuse in the last 2 years.
  • Participation in another study of a drug or device within 30 days after randomization.
  • Inability to communicate and to comply with all such obligations including the unwillingness or inability to give an informed consent.
  • Residence in urban centers without environmental monitoring.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01723761

Locations
Italy
Ospedale S.Maria dei Battuti - Cardiologia
Conegliano, Italy, 31015
Ospedale di ESte
Este, Italy, 35042
Mater Salutis
Legnago, Italy, 37045
Dell'Angelo Hospital
Mestre, Italy, 30175
Ospedale Civile
Mirano, Italy, 30039
Ospedale S. Valentino
Montebelluna, Italy, 31044
Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova
Padova, Italy, 35128
Civic Hospital
Portogruaro, Italy, 30026
Ospedale Ca' Foncello - Divisione di Cardiologia
Treviso, Italy, 31100
Sponsors and Collaborators
Effect Group, Italy
Investigators
Principal Investigator: Gianfranco Buja, MD University of Padua
  More Information

No publications provided

Responsible Party: Effect Group, Italy
ClinicalTrials.gov Identifier: NCT01723761     History of Changes
Other Study ID Numbers: ARIAPOL 01
Study First Received: October 23, 2012
Last Updated: April 2, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Effect Group, Italy:
air pollution
pacemaker
ICD
remote monitoring
supraventricular arrhythmias
ventricular arrhythmias

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014