- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00809432
The Cardiovascular Benefits of Reducing Personal Exposure to Air Pollution
December 15, 2008 updated by: University of Edinburgh
Beneficial Cardiovascular Effects of Reducing Exposure to Particulate Air Pollution With a Simple Facemask
Exposure to air pollution is an important risk factor for cardiovascular morbidity and mortality, and is associated with increased blood pressure, reduced heart rate variability, endothelial dysfunction and myocardial ischaemia.
The study objectives were to assess the potential cardiovascular benefits of reducing personal particulate air pollution exposure by wearing a facemask in healthy volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China
- Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Medical Union College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- Current smokers
- Significant occupational exposure to air pollution
- Regular medication use (except oral contraceptive pill)
- Intercurrent illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Visit 1
2 hour city centre kerbside walk in Beijing China
|
Subjects will not wear a face mask to reduce their personal exposure to air pollution
|
Experimental: Visit 2
2 hour city centre kerbside walk in Beijing China
|
Subjects to wear a simple face mask for 24 hours prior to the study day and the 24 hours of the study day.
They will be instructed to wear the mask as much as possible when indoors and at all times when outdoors.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ambulatory blood pressure
Time Frame: During 24 hour study period
|
During 24 hour study period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart rate
Time Frame: During 24 hour study period
|
During 24 hour study period
|
Heart rate variability
Time Frame: During 24 hour study period
|
During 24 hour study period
|
Personal air pollution exposure
Time Frame: During 2 hour city centre walk
|
During 2 hour city centre walk
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeremy P Langrish, MB BCh MRCP, University of Edinburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
December 15, 2008
First Submitted That Met QC Criteria
December 15, 2008
First Posted (Estimate)
December 17, 2008
Study Record Updates
Last Update Posted (Estimate)
December 17, 2008
Last Update Submitted That Met QC Criteria
December 15, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- 167/2008/Pilot
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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