Correlations Between Arrhythmias and Air Pollution in Patients With Pacemaker and ICD
NCT01723761 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 473
Last updated 2015-07-02
Summary
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.
Conditions
Sponsors & Collaborators
-
Effect Group, Italy
lead NETWORK
Principal Investigators
-
Gianfranco Buja, MD · University of Padova
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2013-11-30
- Completion
- 2015-06-30
Countries
- Italy
Study Locations
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