Cardiac Vulnerability in Potentially Susceptible Patients

This study has been completed.
Sponsor:
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00012493
First received: March 9, 2001
Last updated: September 1, 2006
Last verified: September 2006

March 9, 2001
September 1, 2006
October 1999
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Complete list of historical versions of study NCT00012493 on ClinicalTrials.gov Archive Site
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Cardiac Vulnerability in Potentially Susceptible Patients
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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.

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.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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Heart Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2002
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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.

Both
45 Years to 74 Years
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00012493
9825-CP-001
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National Institute of Environmental Health Sciences (NIEHS)
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Principal Investigator: Frank E Speizer, MD Environmental Epidemiology Program, Department of Environmental Health, Harvard School of Public Health
National Institute of Environmental Health Sciences (NIEHS)
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP