Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011310
Status:
COMPLETED
Last Update Posted:
2006-09-04
First Post:
2001-02-15
Brief Title:
Cardiopulmonary Effects of Particulate Exposure
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:
The aim of this study is to assess cardiac rate and respiratory responses and rhythm after workplace exposure to combustion particulates A repeated measurement study is being performed on acute boilermakers apprentices and journeymen A stratified analysis is then done on those with and without chronic bronchitis after adjustment for relevant covariates
Detailed Description:
Population-based epidemiologic studies of communities in the United States have revealed a consistent association between ambient particulate air pollution and increases in morbidity and mortality The observed increases result from both respiratory and cardiovascular diseases Similar associations have been observed for rates of hospital admissions for respiratory and cardiovascular diseases for subjects over age 65 These ambient exposures are to low levels of particulates many times lower than occupational exposures faced by workers in a variety of industries including manufacturing construction transportation and electric-power generation The objective of this proposal is to investigate the role of occupational exposure to particulates in the development of respiratory and cardiac responses in boilermakers We will employ a detailed continuous-exposure assessment to PM25 with repeated measures of biologic and physiologic markers of response Specific hypotheses to be tested will include 1 occupational exposure to fuel-oil ash particulates induce airway inflammation as reflected in increased expired NO and airflow obstruction as reflected in decreases in peak flow PEFR and FEV1 2 particulate exposure will result in acute changes in cardiovascular function as reflected in changes in heart rate heart-rate variability and blood pressure 3 particulate exposures result in increased serum fibrinogen levels a known risk factor for cardiovascular disease and 4 chronic bronchitis predisposes particulate-exposed workers to changes in cardiac function The results of this study will have important implications for preventive efforts aimed at reducing morbidity and mortality from occupational exposure to respirable particulates
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