Cardiovascular Vulnerability to Particulate Exposure

Heart Disease Clinical Trial

Official title:

Active Elderly Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00013949
• Other study ID #: 9825-CP-003
• Status: Completed
• Phase: N/A
• First received: April 3, 2001
• Last updated: September 1, 2006
• Start date: September 1998
• Est. completion date: September 2004

Study information

• Verified date: September 2006
• Source: National Institute of Environmental Health Sciences (NIEHS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Heart Disease
• Lung Disease
• Lung Diseases

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States,