Full Text View
Tabular View
No Study Results Posted
Related Studies
Air Pollution and Implantable Cardioverter Defibrillators
This study has been completed.
Study NCT00015574   Information provided by National Institute of Environmental Health Sciences (NIEHS)
First Received: April 20, 2001   Last Updated: September 1, 2006   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

April 20, 2001
September 1, 2006
September 1998
 
 
Complete list of historical versions of study NCT00015574 on ClinicalTrials.gov Archive Site
 
 
 
Air Pollution and Implantable Cardioverter Defibrillators
 

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.

 
Observational
Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
Arrythmias
 
 
Peters A, Liu E, Verrier RL, Schwartz J, Gold DR, Mittleman M, Baliff J, Oh JA, Allen G, Monahan K, Dockery DW. Air pollution and incidence of cardiac arrhythmia. Epidemiology. 2000 Jan;11(1):11-7.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
500
September 2004
 

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.

Both
up to 90 Years
No
 
United States
 
 
NCT00015574
 
 
National Institute of Environmental Health Sciences (NIEHS)
Tufts Medical Center
Study Director: Douglas Dockery, ScD Harvard School of Public Health
National Institute of Environmental Health Sciences (NIEHS)
September 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.