Correlations Between Arrhythmias and Air Pollution in Patients With Pacemaker and ICD (ARIA)
|ClinicalTrials.gov Identifier: NCT01723761|
Recruitment Status : Completed
First Posted : November 8, 2012
Last Update Posted : July 2, 2015
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 or disease|
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|Study Type :||Observational|
|Actual Enrollment :||473 participants|
|Official Title:||Correlations Between Arrhythmias, Climatic Variables and Air Pollution in Patients With Pacemaker and ICD, Followed by Remote Monitoring.|
|Study Start Date :||April 2011|
|Primary Completion Date :||November 2013|
|Study Completion Date :||June 2015|
- incidence of atrial arrhythmias. [ Time Frame: 12- 24 months. ]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 ]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.
- Mean heart rate [ Time Frame: 12-24 months ]Mean heart rate obtained by remote monitoring of pacemaker and ICDs.
- Heart rate variability [ Time Frame: 12-24 months ]Measures of heart rate variability calculated by devices and obtained by remote monitoring.
- Percentage of paced beats [ Time Frame: 12-24 months ]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 ]
- Hospitalization for myocardial infarction or heart failure. [ Time Frame: 12-24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723761
|Ospedale S.Maria dei Battuti - Cardiologia|
|Conegliano, Italy, 31015|
|Ospedale di ESte|
|Este, Italy, 35042|
|Legnago, Italy, 37045|
|Mestre, Italy, 30175|
|Mirano, Italy, 30039|
|Ospedale S. Valentino|
|Montebelluna, Italy, 31044|
|Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova|
|Padova, Italy, 35128|
|Portogruaro, Italy, 30026|
|Ospedale Ca' Foncello - Divisione di Cardiologia|
|Treviso, Italy, 31100|
|Principal Investigator:||Gianfranco Buja, MD||University of Padua|