The Cardiovascular Benefits of Reducing Personal Exposure to Air Pollution

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University of Edinburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 14, 2014