The Cardiovascular Benefits of Reducing Personal Exposure to Air Pollution

Blood Pressure Clinical Trial

Official title:

Beneficial Cardiovascular Effects of Reducing Exposure to Particulate Air Pollution With a Simple Facemask

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809432
• Other study ID #: 167/2008/Pilot
• Status: Completed
• Phase: N/A
• First received: December 15, 2008
• Last updated: December 15, 2008
• Start date: August 2008
• Est. completion date: August 2008

Study information

• Verified date: December 2008
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Current smokers

• Significant occupational exposure to air pollution

• Regular medication use (except oral contraceptive pill)

• Intercurrent illness

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Blood Pressure
• Heart Rate Variability

Intervention

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:
• No Face mask
Subjects will not wear a face mask to reduce their personal exposure to air pollution

Locations

Country	Name	City	State
China	Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Medical Union College	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory blood pressure		During 24 hour study period	No
Secondary	Heart rate		During 24 hour study period	No
Secondary	Heart rate variability		During 24 hour study period	No
Secondary	Personal air pollution exposure		During 2 hour city centre walk	No