Cardiac Vulnerability in Potentially Susceptible Patients

This study has been completed.

First Received: March 9, 2001 Last Updated: September 1, 2006 History of Changes

Sponsor:	National Institute of Environmental Health Sciences (NIEHS)
Information provided by:	National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:	NCT00012493

Purpose

This project is part of a program project directed toward assessing cardiac effects of particulate and other ambient air pollutants. In this project patient who have recently suffered a cardiac event are being monitored with cardiac monitors for 24 hours up to 4 times during the year following their cardiac event. Similarly a second group of patients with moderate to severe heart failure will undergo similar cardiac monitoring for 24 hours, twice a week separated by 3 months. In both sets of patients home indoor pollution measures will be continuously made and used to correlate with measures of heart rate variability.

Condition
Heart Disease

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases

U.S. FDA Resources

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

Estimated Enrollment:	100
Study Start Date:	October 1999
Estimated Study Completion Date:	December 2002

Detailed Description:

Approximately 50 patients in each group will be studied. In addition to cardiac monitoring for 24 hours at each session, overnight respiratory pattern and oxygen saturation will be monitored in both groups. The exposure monitoring will include both particle mass of PM2.5 along with detailed assessment to determine that portion of the particulate exposure from outdoor vs. indoor sources.

Eligibility

Ages Eligible for Study:	45 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

For the cardiac event cases patients are selected from the Brigham and Women's Hospital cardiac services at the time of discharge, aged 45-74, having suffered a cardiac event resulting in either an infarct or need for a cardiac procedure (angioplasty, stint, etc). For the CHF patients they are selected from the BWH cardiac clinics where they have been identified and classified as stage 3 or 4 CHF. For both groups residence requirements are that they reside within the Greater Boston Area as defined by an outer ring road (Route 495) and are willing to be visited at home and have the exposure assessment equipment set up in their home as well as be monitored personally.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012493

Locations

United States, Massachusetts
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

National Institute of Environmental Health Sciences (NIEHS)

Investigators

Principal Investigator:

Frank E Speizer, MD

Environmental Epidemiology Program, Department of Environmental Health, Harvard School of Public Health

More Information

No publications provided

Study ID Numbers:	9825-CP-001
Study First Received:	March 9, 2001
Last Updated:	September 1, 2006
ClinicalTrials.gov Identifier:	NCT00012493 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):

Cardiac event
Heart disease
Particulate Matter

Additional relevant MeSH terms:

Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 27, 2009