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Air Pollution and Implantable Cardioverter Defibrillators

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00015574
Enrollment
500
Registered
2001-04-23
Start date
1998-09-30
Completion date
2004-09-30
Last updated
2006-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrythmias

Keywords

arrhythmia, cardiac, air pollution, time series

Brief summary

Community based studies have shown increased cardiovascular mortality associated with acute exposures to particulate air pollution. Electrocardiographic changes have also been reported in animals exposed to particles in controlled conditions. We have hypothesized that cardiovascular patients may experience life-threatening arrhythmias associated with particulate air pollution episodes. Implanted cardioverter defibrillator (ICD) devices continuously monitor the heart rhythm, and on detecting arrhythmias can initiate interventions. These devices provide a passive, continuous monitor of cardiac arrhythmias. We are assessing the association between community exposures to air pollution measured by ambient monitors and these cardiac arrhythmias detected by implanted cardioverter defibrillator devices.

Detailed description

Records of cardiac arrhythmias detected in patients with implanted cardioverter defibrillators will be linked with measurements of the concentration and constituents of ambient particulate air pollution. Time series methods will be used to assess temporal associations, adjusting for seasonal, weekly, and diurnal patterns, meteorology, and co-pollutants. Characteristics of subjects showing the strongest air pollution associations will be assessed, as well as effect modification by medication and co-morbidities. ICD patients are followed up clinically every three to six months. The ICD device is interrogated and data are retrieved by non-invasive radio frequency retrieval from the implanted device. Device performance is checked. Detected arrhythmias and therapeutic interventions are listed. For each detected episode, date and time is recorded, along with a short electrogram of the heartbeats immediately before and during the event. Daily ambient particle mass (PM10 and PM2.5) and particle constituents have been measured in Boston since January 1995. The Massachusetts Department of Environmental Protection has measured concentrations of gaseous pollutants including carbon monoxide, nitrogen dioxide, ozone, and sulfur dioxide. Meteorological factors including temperature, humidity, and barometric pressure have been measured at the National Weather Service station at Logan airport. Meteorologic factors and gaseous co-pollutants will be considered as independent predictors of arrhythmic events, and as confounders of the particulate air pollution associations.

Interventions

None listed

Sponsors

Tufts Medical Center
CollaboratorOTHER
National Institute of Environmental Health Sciences (NIEHS)
Lead SponsorNIH

Study design

Observational model
DEFINED_POPULATION
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
0 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

The sample population consists of cardiac patients with implanted cardioverter defibrillator devices attending device clinics at the New England Medical Center (NEMC) Cardiac Electrophysiology and Pacemaker Laboratory. All patients with implanted ICD devices with event time and date recording living in the greater Boston area will be included.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026