Cardiopulmonary Effects of Particulate Exposure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

1999-03-31

Study Completion Date

2002-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Tract Diseases Cardiac Diseases Bronchitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Particulates Air Pollution Cardiopulmonary Disease Lung Inflammation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Adults; Over 18; Boilermakers

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Harvard School of Public Health

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

9860-CP-001

Identifier Type: -

Identifier Source: org_study_id