Cardiac Vulnerability in Potentially Susceptible Patients

Heart Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00012493
• Other study ID #: 9825-CP-001
• Status: Completed
• Phase: N/A
• First received: March 9, 2001
• Last updated: September 1, 2006
• Start date: October 1999
• Est. completion date: December 2002

Study information

• Verified date: September 2006
• Source: National Institute of Environmental Health Sciences (NIEHS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 74 Years

Eligibility

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.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases

Locations

Country	Name	City	State
United States	Brigham and Womens Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States,