Air Pollution and Implantable Cardioverter Defibrillators

Arrythmias Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00015574
• Other study ID #: 9825-CP-002
• Status: Completed
• Phase: N/A
• First received: April 20, 2001
• Last updated: September 1, 2006
• Start date: September 1998
• Est. completion date: September 2004

Study information

• Verified date: September 2006
• Source: National Institute of Environmental Health Sciences (NIEHS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 90 Years

Eligibility

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.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Arrythmias

Locations

Country	Name	City	State
United States	New England Medical Center, Cardiac Arrhythmia Service	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Environmental Health Sciences (NIEHS)	Tufts Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation