NCT00015574

Brief Summary

Community based studies have shown increased cardiovascular mortality associated with acute exposures to particulate air pollution. Electrocardiographic changes have also been reported in animals exposed to particles in controlled conditions. We have hypothesized that cardiovascular patients may experience life-threatening arrhythmias associated with particulate air pollution episodes. Implanted cardioverter defibrillator (ICD) devices continuously monitor the heart rhythm, and on detecting arrhythmias can initiate interventions. These devices provide a passive, continuous monitor of cardiac arrhythmias. We are assessing the association between community exposures to air pollution measured by ambient monitors and these cardiac arrhythmias detected by implanted cardioverter defibrillator devices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 1998

Longer than P75 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

September 1, 1998

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2001

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

September 4, 2006

Status Verified

September 1, 2006

First QC Date

April 20, 2001

Last Update Submit

September 1, 2006

Conditions

Arrythmias

Keywords

arrhythmiacardiacair pollutiontime series

Eligibility Criteria

Age0 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
The sample population consists of cardiac patients with implanted cardioverter defibrillator devices attending device clinics at the New England Medical Center (NEMC) Cardiac Electrophysiology and Pacemaker Laboratory. All patients with implanted ICD devices with event time and date recording living in the greater Boston area will be included.

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

Sponsors & Collaborators

Study Sites (1)

New England Medical Center, Cardiac Arrhythmia Service

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

  • Peters A, Liu E, Verrier RL, Schwartz J, Gold DR, Mittleman M, Baliff J, Oh JA, Allen G, Monahan K, Dockery DW. Air pollution and incidence of cardiac arrhythmia. Epidemiology. 2000 Jan;11(1):11-7. doi: 10.1097/00001648-200001000-00005.

    PMID: 10615837BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Douglas Dockery, ScD

    Harvard School of Public Health (HSPH)

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 20, 2001

First Posted

April 23, 2001

Study Start

September 1, 1998

Study Completion

September 1, 2004

Last Updated

September 4, 2006

Record last verified: 2006-09

Locations

US(1)