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| Tracking Information | |||||
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| First Received Date ICMJE | March 9, 2001 | ||||
| Last Updated Date | September 1, 2006 | ||||
| Start Date ICMJE | October 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00012493 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cardiac Vulnerability in Potentially Susceptible Patients | ||||
| Official Title ICMJE | |||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History, Longitudinal, Defined Population, Prospective Study | ||||
| Condition ICMJE | Heart Disease | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | December 2002 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||
| Ages | 45 Years to 74 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00012493 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 9825-CP-001 | ||||
| Study Sponsor ICMJE | National Institute of Environmental Health Sciences (NIEHS) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Environmental Health Sciences (NIEHS) | ||||
| Verification Date | September 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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