Reducing the Pro-ischaemic Effects of Air Pollution Exposure Using a Simple Face Mask
1 other identifier
interventional
100
1 country
1
Brief Summary
Air pollution is a major cause of cardiorespiratory morbidity and mortality. The exact components of air pollution that underlie the cardiovascular effects are not yet known, but combustion-derived particulate matter is suspected to be the major cause. Epidemiological studies have shown that exposure to air pollution causes exacerbation of existing cardiorespiratory conditions leading to increased hospital admissions and death. The investigators have recently conducted a series of controlled exposure studies to urban particulate matter and diesel exhaust in healthy volunteers and patients with coronary heart disease. The investigators found that controlled exposure to dilute diesel exhaust in patients with prior myocardial infarction induced asymptomatic myocardial ischaemia with an increase in electrocardiographic measures of myocardial ischaemia. Whilst important, further questions remain: (i) does air pollution exposure exacerbate ischaemia and reduce exercise tolerance in patients with symptomatic angina pectoris, (ii) do "real world" exposures as encountered in the urban environment of major cities have similar effects, and (iii) can a simple face mask intervention to reduce exposure to particulate air pollution improve health outcomes in patients with coronary heart disease?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2008
CompletedFirst Posted
Study publicly available on registry
December 17, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedMarch 31, 2010
May 1, 2009
4 months
December 15, 2008
March 30, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myocardial ischaemic burden determined using continuous electrographic monitoring
During 2 hour walk and subsequent 24 hour period
Secondary Outcomes (7)
Symptoms of angina pectoris assessed by patient diary and GTN use
During 2 hour walk and subsequent 24 hour period
Biochemical markers of myocardial ischaemia
After 2 hour city centre walk
Systemic inflammatory markers
After 2 hour city centre walk
Blood pressure
During 2 hour walk and for subsequent 24 hours
Heart rate and heart rate variability
During 2 hour walk and subsequent 24 hour period
- +2 more secondary outcomes
Study Arms (2)
Visit 1
EXPERIMENTAL2 hour walk in city centre location in Beijing China
Visit 2
EXPERIMENTAL2 hour walk in city centre location in Beijing China
Interventions
Subjects will not wear a face mask to reduce their personal air pollution exposure
Subjects will be asked to wear a simple face mask to reduce personal exposure to particulate air pollution. Subjects will be asked to wear the 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 at all times when outdoors and as much as possible when indoors.
Eligibility Criteria
You may qualify if:
- Stable coronary heart disease
- Symptoms of angina pectoris
- Evidence of coronary heart disease by angiography or by exercise stress testing
You may not qualify if:
- Current smokers
- History of arrhythmia
- Severe 3 vessel coronary heart disease or left main stem stenosis that has not been revascularised
- Resting conduction abnormality
- Digoxin therapy
- Uncontrolled hypertension
- Renal failure
- Hepatic failure
- Acute coronary syndrome or unstable symptoms within 3 months
- Significant occupation exposure to air pollution
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Medical Union College
Beijing, China
Related Publications (3)
Mills NL, Tornqvist H, Gonzalez MC, Vink E, Robinson SD, Soderberg S, Boon NA, Donaldson K, Sandstrom T, Blomberg A, Newby DE. Ischemic and thrombotic effects of dilute diesel-exhaust inhalation in men with coronary heart disease. N Engl J Med. 2007 Sep 13;357(11):1075-82. doi: 10.1056/NEJMoa066314.
PMID: 17855668BACKGROUNDLangrish JP, Watts SJ, Hunter AJ, Shah AS, Bosson JA, Unosson J, Barath S, Lundback M, Cassee FR, Donaldson K, Sandstrom 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.
PMID: 24667535DERIVEDLangrish JP, Li X, Wang S, Lee MM, Barnes GD, Miller MR, Cassee FR, Boon NA, Donaldson K, Li J, Li L, Mills NL, Newby DE, Jiang L. Reducing personal exposure to particulate air pollution improves cardiovascular health in patients with coronary heart disease. Environ Health Perspect. 2012 Mar;120(3):367-72. doi: 10.1289/ehp.1103898.
PMID: 22389220DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lixin Jiang, MD
Chinese Academy of Medical Sciences and Peking Medical Union College
- PRINCIPAL INVESTIGATOR
David E Newby, PhD FRCP
University of Edinburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 15, 2008
First Posted
December 17, 2008
Study Start
January 1, 2009
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
March 31, 2010
Record last verified: 2009-05