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Home > "A" Clinical Trials Conditions > Air Pollution and Implantable Cardioverter Defibrillators  Air Pollution and Implantable Cardioverter Defibrillators
Air Pollution and Implantable Cardioverter Defibrillators
For Condition: arrythmias
Status: Recruiting
Sponsor(s): National Institute of Environmental Health Sciences (NIEHS) , New England Medical Center
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
Minimum Age/Maximum Age: /90 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 500
Location and Contact Information:
Overall Study Official:
DouglasDockery, Study Director, Harvard School of Public Health
New England Medical Center, Cardiac Arrhythmia Service *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting Mark Link 617-636-8994
Additional Information:
Study ID Numbers: 9825-CP-002;
Study Start Date: September 1998
Record last reviewed: April 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015574
Other Arrythmias Studies:
1. Air Pollution and Implantable Cardioverter Defibrillators
Related Studies:
Other arrythmias Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Air Pollution and Implantable Cardioverter Defibrillators
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