The Cardiovascular Benefits of Reducing Personal Exposure to Air Pollution
This study has been completed.
Sponsor:
University of Edinburgh
Collaborator:
Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00809432
First received: December 15, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Blood Pressure Heart Rate Variability |
Device: Face mask (Dust Respirator) Other: No Face mask |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Beneficial Cardiovascular Effects of Reducing Exposure to Particulate Air Pollution With a Simple Facemask |
Resource links provided by NLM:
Further study details as provided by University of Edinburgh:
Primary Outcome Measures:
- Ambulatory blood pressure [ Time Frame: During 24 hour study period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Heart rate [ Time Frame: During 24 hour study period ] [ Designated as safety issue: No ]
- Heart rate variability [ Time Frame: During 24 hour study period ] [ Designated as safety issue: No ]
- Personal air pollution exposure [ Time Frame: During 2 hour city centre walk ] [ Designated as safety issue: No ]
| Enrollment: | 15 |
| Study Start Date: | August 2008 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Visit 1
2 hour city centre kerbside walk in Beijing China
|
Other: No Face mask
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
|
Device: Face mask (Dust Respirator)
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 Name: 3M Dust Respirator 8812
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- Current smokers
- Significant occupational exposure to air pollution
- Regular medication use (except oral contraceptive pill)
- Intercurrent illness
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809432
Locations
| China | |
| Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Medical Union College | |
| Beijing, China | |
Sponsors and Collaborators
University of Edinburgh
Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing
Investigators
| Principal Investigator: | Jeremy P Langrish, MB BCh MRCP | University of Edinburgh |
More Information
No publications provided
| Responsible Party: | Professor David E Newby, University of Edinburgh |
| ClinicalTrials.gov Identifier: | NCT00809432 History of Changes |
| Other Study ID Numbers: | 167/2008/Pilot |
| Study First Received: | December 15, 2008 |
| Last Updated: | December 15, 2008 |
| Health Authority: | China: Ethics Committee |
Keywords provided by University of Edinburgh:
|
Air pollution Heart rate Heart rate variability Blood pressure Face mask |
ClinicalTrials.gov processed this record on May 22, 2013