Cardiac Vulnerability in Potentially Susceptible Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-10-31

Study Completion Date

2002-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cardiac event Heart disease Particulate Matter

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Frank E Speizer, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brigham and Womens Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

9825-CP-001

Identifier Type: -

Identifier Source: org_study_id