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The Cardiovascular Benefits of Reducing Personal Exposure to Air Pollution

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ClinicalTrials.gov Identifier: NCT00809432
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : December 17, 2008
Sponsor:
Collaborator:
Peking Union Medical College
Information provided by:
University of Edinburgh

Tracking Information
First Submitted Date  ICMJE December 15, 2008
First Posted Date  ICMJE December 17, 2008
Last Update Posted Date December 17, 2008
Study Start Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2008)
Ambulatory blood pressure [ Time Frame: During 24 hour study period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2008)
  • Heart rate [ Time Frame: During 24 hour study period ]
  • Heart rate variability [ Time Frame: During 24 hour study period ]
  • Personal air pollution exposure [ Time Frame: During 2 hour city centre walk ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Cardiovascular Benefits of Reducing Personal Exposure to Air Pollution
Official Title  ICMJE Beneficial Cardiovascular Effects of Reducing Exposure to Particulate Air Pollution With a Simple Facemask
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Blood Pressure
  • Heart Rate Variability
Intervention  ICMJE
  • 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
  • Other: No Face mask
    Subjects will not wear a face mask to reduce their personal exposure to air pollution
Study Arms  ICMJE
  • Experimental: Visit 1
    2 hour city centre kerbside walk in Beijing China
    Intervention: Other: No Face mask
  • Experimental: Visit 2
    2 hour city centre kerbside walk in Beijing China
    Intervention: Device: Face mask (Dust Respirator)
Publications * Langrish JP, Watts SJ, Hunter AJ, Shah AS, Bosson JA, Unosson J, Barath S, Lundbäck M, Cassee FR, Donaldson K, Sandström T, Blomberg A, Newby DE, Mills NL. Controlled exposures to air pollutants and risk of cardiac arrhythmia. Environ Health Perspect. 2014 Jul;122(7):747-53. doi: 10.1289/ehp.1307337. Epub 2014 Mar 25. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2008)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Current smokers
  • Significant occupational exposure to air pollution
  • Regular medication use (except oral contraceptive pill)
  • Intercurrent illness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00809432
Other Study ID Numbers  ICMJE 167/2008/Pilot
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor David E Newby, University of Edinburgh
Study Sponsor  ICMJE University of Edinburgh
Collaborators  ICMJE Peking Union Medical College
Investigators  ICMJE
Principal Investigator: Jeremy P Langrish, MB BCh MRCP University of Edinburgh
PRS Account University of Edinburgh
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP