Arrythmias Clinical Trial
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.
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.
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Observational Model: Defined Population, Time Perspective: Longitudinal
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06260384 -
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| Completed |
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Phase 3 |