We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiopulmonary Effects of Particulate Exposure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00011310
First Posted: February 19, 2001
Last Update Posted: September 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
  Purpose
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.

Condition
Respiratory Tract Diseases Cardiac Diseases Bronchitis

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective

Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Study Start Date: March 1999
Estimated Study Completion Date: February 2002
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 PM2.5 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Adults; Over 18; Boilermakers
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00011310


Locations
United States, Massachusetts
Harvard School of Public Health
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
  More Information

ClinicalTrials.gov Identifier: NCT00011310     History of Changes
Other Study ID Numbers: 9860-CP-001
First Submitted: February 15, 2001
First Posted: February 19, 2001
Last Update Posted: September 4, 2006
Last Verified: September 2006

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Particulates
Air Pollution
Cardiopulmonary Disease
Lung
Inflammation

Additional relevant MeSH terms:
Bronchitis
Heart Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Cardiovascular Diseases