Heart DiseaseNCT00013949
Cardiovascular Vulnerability to Particulate Exposure
An observational study of Heart Disease and Lung Disease, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
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 active elderly adults living in the communities of Boston and Steubenville have attended 12 weekly sessions including approximately 40 minutes of Holter monitoring, blood… Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Disease, Lung Disease
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1998to Sep 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Participants are 50 to 90 years of age, but almost all are 60 and older. They have been enrolled as volunteers from communities in Mission Park, Boston, and Steubenville. Inclusion criteria includes the ability to walk on level ground. Exclusion criteria includes unstable anginal, and baseline EKG patterns such as left bundle branch block that would make difficult the detection of repolarization abnormalities. Participants live at or near the study center which was located in an office or apartment in the apartment building of the majority of the participants.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Active Elderly Study
This project is part of a program project directed toward assessing cardiac effects of particulate and other ambient air pollutants. In this project active elderly adults living in the communities of Boston and Steubenville have attended 12 weekly sessions including approximately 40 minutes of Holter monitoring, blood pressure, and oximetry evaluation before, during, and after outdoor exercise. To investigate the relation of air pollution to cardiac and pulmonary rehabilitation, a second portion of this study involves abstraction of blood pressure and symptom data and downloading of available repeated measures telemetry data in two populations. These populations include: 1) 200 outpatients attending 8 to 36 repeated weekly exercise training sessions in a major hospital cardiac rehabilitation unit.
Read the detailed description
Approximately 60 subjects have participated fully in Boston and Steubenville in the repeated 40 minute measurement of continuous EKG (Holter), blood pressure, and oximetry. In Steubenville we have also measured exhaled nitrogen oxide, an index of pulmonary inflammation. The exposure monitoring has included outdoor particle mass of PM2.5, outdoor gaseous pollutants, and indoor home and personal monitoring to evaluate the indoor contribution of pollution to health effects.
- Conditions
- Heart Disease, Lung Disease
- Keywords
- Holter monitoring, ECG, Cardiac, particulate exposure
- Medical subject headings
- Heart Diseases, Lung Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2001 (estimated)
- Study startSep 1998
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Diane Gold, MD, Study director, Harvard School of Public Health (HSPH)Frank E Speizer, MD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013949
- Sponsor's protocol ID
- 9825-CP-003
- Status last verified
- Sep 2006
- First submitted
- 3 Apr 2001
- Last updated
- 4 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Elderly Study
- ClinicalTrials.gov ID
- NCT00013949
- Acronym / sponsor ID
- 9825-CP-003
- Conditions
- Heart Disease, Lung Disease
- Keywords
- Holter monitoring, ECG, Cardiac, particulate exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Sep 1998
- Study completion
- Sep 2004
- First posted
- 4 Apr 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is part of a program project directed toward assessing cardiac effects of particulate and other ambient air pollutants. In this project active elderly adults living in the communities of Boston and Steubenville have attended 12 weekly sessions including approximately 40 minutes of Holter monitoring, blood pressure, and oximetry evaluation before, during, and after outdoor exercise. To investigate the relation of air pollution to cardiac and pulmonary rehabilitation, a second portion of this study involves abstraction of blood pressure and symptom data and downloading of available repeated measures telemetry data in two populations. These populations include: 1) 200 outpatients attending 8 to 36 repeated weekly exercise training sessions in a major hospital cardiac rehabilitation unit.
Detailed description
Approximately 60 subjects have participated fully in Boston and Steubenville in the repeated 40 minute measurement of continuous EKG (Holter), blood pressure, and oximetry. In Steubenville we have also measured exhaled nitrogen oxide, an index of pulmonary inflammation. The exposure monitoring has included outdoor particle mass of PM2.5, outdoor gaseous pollutants, and indoor home and personal monitoring to evaluate the indoor contribution of pollution to health effects.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane Gold, MD study director
Harvard School of Public Health (HSPH)
Frank E Speizer, MD principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease and Lung Disease, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2006.