Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015574
Status:
COMPLETED
Last Update Posted:
2006-09-04
First Post:
2001-04-20
Brief Title:
Air Pollution and Implantable Cardioverter Defibrillators
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institute of Environmental Health Sciences NIEHS
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 PM25 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
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 PM25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None