Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012493
Status:
COMPLETED
Last Update Posted:
2006-09-04
First Post:
2001-03-09
Brief Title:
Cardiac Vulnerability in Potentially Susceptible Patients
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institute of Environmental Health Sciences NIEHS
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 PM25 along with detailed assessment to determine that portion of the particulate exposure from outdoor vs indoor sources
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None