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Cardiac Vulnerability in Potentially Susceptible Patients

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ClinicalTrials.gov Identifier: NCT00012493
Recruitment Status : Completed
First Posted : March 12, 2001
Last Update Posted : September 4, 2006
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)

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 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 or disease
Heart Disease

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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : October 1999
Estimated Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT00012493

United States, Massachusetts
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Principal Investigator: Frank E Speizer, MD Environmental Epidemiology Program, Department of Environmental Health, Harvard School of Public Health

ClinicalTrials.gov Identifier: NCT00012493     History of Changes
Other Study ID Numbers: 9825-CP-001
First Posted: March 12, 2001    Key Record Dates
Last Update Posted: September 4, 2006
Last Verified: September 2006

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Cardiac event
Heart disease
Particulate Matter

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases