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Cardiovascular Vulnerability to Particulate Exposure

This study has been completed.
Study NCT00013949.   Last updated on September 1, 2006.   Information provided by National Institute of Environmental Health Sciences (NIEHS)

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Descriptive Information Fields
Brief Title  Cardiovascular Vulnerability to Particulate Exposure
Official Title  Active Elderly Study
Brief Summary

This project is part of a program project directed toward assessing cardiac effects of particulate and other ambient air pollutants. In this project active elderly adults living in the communities of Boston and Steubenville have attended 12 weekly sessions including approximately 40 minutes of Holter monitoring, blood pressure, and oximetry evaluation before, during, and after outdoor exercise. To investigate the relation of air pollution to cardiac and pulmonary rehabilitation, a second portion of this study involves abstraction of blood pressure and symptom data and downloading of available repeated measures telemetry data in two populations. These populations include: 1) 200 outpatients attending 8 to 36 repeated weekly exercise training sessions in a major hospital cardiac rehabilitation unit.

Detailed Description

Approximately 60 subjects have participated fully in Boston and Steubenville in the repeated 40 minute measurement of continuous EKG (Holter), blood pressure, and oximetry. In Steubenville we have also measured exhaled nitrogen oxide, an index of pulmonary inflammation. The exposure monitoring has included outdoor particle mass of PM2.5, outdoor gaseous pollutants, and indoor home and personal monitoring to evaluate the indoor contribution of pollution to health effects.

Study Phase
Study Type  Observational
Study Design  Natural History, Longitudinal, Defined Population, Prospective Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Heart Disease
Lung Disease
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  200
Start Date  September 1998
Completion Date September 2004
Eligibility Criteria 

Participants are 50 to 90 years of age, but almost all are 60 and older. They have been enrolled as volunteers from communities in Mission Park, Boston, and Steubenville. Inclusion criteria includes the ability to walk on level ground. Exclusion criteria includes unstable anginal, and baseline EKG patterns such as left bundle branch block that would make difficult the detection of repolarization abnormalities. Participants live at or near the study center which was located in an office or apartment in the apartment building of the majority of the participants.

Gender Both
Ages 50 Years to 90 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00013949
Organization ID 9825-CP-003
Secondary IDs ††
Study Sponsor  National Institute of Environmental Health Sciences (NIEHS)
Collaborators ††
Investigators 
Study Director:     Diane Gold, MD     Harvard School of Public Health    
Principal Investigator:     Frank E Speizer, MD     Harvard School of Public Health    
Information Provided By National Institute of Environmental Health Sciences (NIEHS)
Verification Date September 2006
First Received Date  April 3, 2001
Last Updated Date September 1, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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