NCT00012493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 1999

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2001

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
Last Updated

September 4, 2006

Status Verified

September 1, 2006

First QC Date

March 9, 2001

Last Update Submit

September 1, 2006

Conditions

Heart Disease

Keywords

Cardiac eventHeart diseaseParticulate Matter

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Heart DiseasesCardiovascular Diseases

Study Officials

  • Frank E Speizer, MD

    Environmental Epidemiology Program, Department of Environmental Health, Harvard School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

March 9, 2001

First Posted

March 12, 2001

Study Start

October 1, 1999

Study Completion

December 1, 2002

Last Updated

September 4, 2006

Record last verified: 2006-09

Locations

US(1)