Correlations Between Arrhythmias and Air Pollution in Patients With Pacemaker and ICD

NCT01723761 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 473

Last updated 2015-07-02

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01723761 on ClinicalTrials.gov