NCT00012493

Completed

Cardiac Vulnerability in Potentially Susceptible Patients

National Institute of Environmental Health Sciences (NIEHS)Source

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Other study identifiers

Sponsor study identifier

9825-CP-001

Study Type

observational

Reported enrollment (type unavailable)

100

Locations

1 country

Sites

1

Timeline

Study Start

October 1999

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

December 2002

Date type not reported

This date has not been verified as actual or estimated.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 100 participants
Study completion date: December 2002
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 1999
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
March 9, 2001
Actual (reported)
First Posted
March 12, 2001
Actual (reported)
Study Completion
December 2002
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: September 4, 2006
Status Verified: September 2006
Last Update Submitted: 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

National Institute of Environmental Health Sciences (NIEHS)
NIHlead

Study Sites (1)

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

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 1999

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

December 2002

Date type not reported

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Last Updated

September 4, 2006

Record last verified: 2006-09

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00012493
Data provider: ClinicalTrials.gov
Source updated: 2006-09-04
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:17 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Study Officials

Study Design

Study Record Dates

Source record

Locations