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Reducing the Pro-ischaemic Effects of Air Pollution Exposure Using a Simple Face Mask

Primary Purpose

Angina Pectoris, Coronary Heart Disease, Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
No Face Mask
Face Mask
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Angina Pectoris focused on measuring Air pollution, Face mask, Myocardial ischaemia, Heart rate variability, Angina pectoris, Coronary heart disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stable coronary heart disease
  • Symptoms of angina pectoris
  • Evidence of coronary heart disease by angiography or by exercise stress testing

Exclusion Criteria:

  • 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

Sites / Locations

  • Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Medical Union College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Visit 1

Visit 2

Arm Description

2 hour walk in city centre location in Beijing China

2 hour walk in city centre location in Beijing China

Outcomes

Primary Outcome Measures

Myocardial ischaemic burden determined using continuous electrographic monitoring

Secondary Outcome Measures

Symptoms of angina pectoris assessed by patient diary and GTN use
Biochemical markers of myocardial ischaemia
Systemic inflammatory markers
Blood pressure
Heart rate and heart rate variability
Personal exposure to air pollutants
Exercise capacity, time to symptoms and time to 1mm ST segment depression on standard treadmill exercise testing

Full Information

First Posted
December 15, 2008
Last Updated
March 30, 2010
Sponsor
University of Edinburgh
Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00809653
Brief Title
Reducing the Pro-ischaemic Effects of Air Pollution Exposure Using a Simple Face Mask
Official Title
Reducing the Pro-ischaemic Effects of Ambient Particulate Air Pollution in Patients With Coronary Heart Disease Using a Simple Face Mask Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Edinburgh
Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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?
Detailed Description
100 patients with stable angina pectoris will be recruited from the HPS-THRIVE cohort or from the cardiology outpatient department at the Fuwai Hospital in Beijing. Patients will attend the department first thing in the morning on two occasions, separated by at least 1 week. All subjects will be fitted with a 12-lead Holter monitor and 24-hour ambulatory blood pressure monitor. They will be issued with a diary to record their activities and symptoms. Patients will be randomised to wear a simple facemask for one of their visits (3M Dust Respirator 8812). When randomised to wear a mask, subjects will be asked to wear the mask as much as possible in the 24 hours prior to the study day and for the 24 hours of the study day (48 hours in total). Subjects will be instructed to wear the mask at all times when outdoors, and as much as possible when indoors. On both visits, patients will be asked to walk along a prespecified route for 2 hours in a city centre location in Beijing. During this period patients will walk at their own pace for 15 mins and rest for 5 mins for a total of 120 mins (6 cycles). After the walk, subjects will return to the department and the pollution equipment switched off. A formal BRUCE protocol exercise stress test will be performed as soon as possible after finishing the 2-hour walk, and blood tests will be taken just prior to the exercise stress test (10-20mls in total). Subjects will be asked to wear the ambulatory blood pressure monitor and the Holter ECG monitor for a total of 24 hours, returning the following day to have this removed. Personal exposure to air pollution will be determined during the 2 hour walk with a series of monitors contained within a small backpack.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Coronary Heart Disease, Blood Pressure, Heart Rate Variability
Keywords
Air pollution, Face mask, Myocardial ischaemia, Heart rate variability, Angina pectoris, Coronary heart disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Visit 1
Arm Type
Experimental
Arm Description
2 hour walk in city centre location in Beijing China
Arm Title
Visit 2
Arm Type
Experimental
Arm Description
2 hour walk in city centre location in Beijing China
Intervention Type
Device
Intervention Name(s)
No Face Mask
Intervention Description
Subjects will not wear a face mask to reduce their personal air pollution exposure
Intervention Type
Device
Intervention Name(s)
Face Mask
Other Intervention Name(s)
3M Dust Respirator 8812
Intervention Description
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.
Primary Outcome Measure Information:
Title
Myocardial ischaemic burden determined using continuous electrographic monitoring
Time Frame
During 2 hour walk and subsequent 24 hour period
Secondary Outcome Measure Information:
Title
Symptoms of angina pectoris assessed by patient diary and GTN use
Time Frame
During 2 hour walk and subsequent 24 hour period
Title
Biochemical markers of myocardial ischaemia
Time Frame
After 2 hour city centre walk
Title
Systemic inflammatory markers
Time Frame
After 2 hour city centre walk
Title
Blood pressure
Time Frame
During 2 hour walk and for subsequent 24 hours
Title
Heart rate and heart rate variability
Time Frame
During 2 hour walk and subsequent 24 hour period
Title
Personal exposure to air pollutants
Time Frame
During 2 hour walk
Title
Exercise capacity, time to symptoms and time to 1mm ST segment depression on standard treadmill exercise testing
Time Frame
Immediately after 2 hour city centre walk

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable coronary heart disease Symptoms of angina pectoris Evidence of coronary heart disease by angiography or by exercise stress testing Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lixin Jiang, MD
Organizational Affiliation
Chinese Academy of Medical Sciences and Peking Medical Union College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David E Newby, PhD FRCP
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Medical Union College
City
Beijing
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
17855668
Citation
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.
Results Reference
background
PubMed Identifier
24667535
Citation
Langrish 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.
Results Reference
derived
PubMed Identifier
22389220
Citation
Langrish 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.
Results Reference
derived

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Reducing the Pro-ischaemic Effects of Air Pollution Exposure Using a Simple Face Mask

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