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Angina PectorisNCT00809653

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

A study testing No Face Mask and Face Mask in people with Angina Pectoris and Coronary Heart Disease, run by University of Edinburgh at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
No Face Mask and Face Mask
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
Jan 2009to May 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • Renal failure
  • Hepatic failure
  • Acute coronary syndrome or unstable symptoms within 3 months
  • Significant occupation exposure to air pollution

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Beijing

Other trials in China

About this study

Official title: Reducing the Pro-ischaemic Effects of Ambient Particulate Air Pollution in Patients With Coronary Heart Disease Using a Simple Face Mask Intervention

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?

Read the 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.

Being tested
No Face Mask, Face Mask
Keywords
Air pollution, Face mask, Myocardial ischaemia, Heart rate variability, Angina pectoris, Coronary heart disease
Medical subject headings
Angina Pectoris, Coronary Disease, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No Face MaskDevice

    Subjects will not wear a face mask to reduce their personal air pollution exposure

  • Face MaskDevice

    Also called 3M Dust Respirator 8812

    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.

Study groups in NCT00809653
Study groupRoleWhat they receive
Visit 1Experimental2 hour walk in city centre location in Beijing China
Receives: Device: No Face Mask
Visit 2Experimental2 hour walk in city centre location in Beijing China
Receives: Device: Face Mask

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myocardial ischaemic burden determined using continuous electrographic monitoring

    Measured: During 2 hour walk and subsequent 24 hour period

Secondary outcomes (7)

  1. Symptoms of angina pectoris assessed by patient diary and GTN use

    Measured: During 2 hour walk and subsequent 24 hour period

  2. Biochemical markers of myocardial ischaemia

    Measured: After 2 hour city centre walk

  3. Systemic inflammatory markers

    Measured: After 2 hour city centre walk

  4. Blood pressure

    Measured: During 2 hour walk and for subsequent 24 hours

  5. Heart rate and heart rate variability

    Measured: During 2 hour walk and subsequent 24 hour period

  6. Personal exposure to air pollutants

    Measured: During 2 hour walk

  7. Exercise capacity, time to symptoms and time to 1mm ST segment depression on standard treadmill exercise testing

    Measured: Immediately after 2 hour city centre walk

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionMay 2009
  4. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00809653
Sponsor's protocol ID
167/2008/Patient
Status last verified
May 2009
First submitted
15 Dec 2008
Last updated
31 Mar 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17855668

  • 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.

    PubMed 24667535

  • 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.

    PubMed 22389220

Questions about this trial

What is this clinical trial studying?

A study testing No Face Mask and Face Mask in people with Angina Pectoris and Coronary Heart Disease, run by University of Edinburgh at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial ischaemic burden determined using continuous electrographic monitoring (time frame: During 2 hour walk and subsequent 24 hour period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00809653, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2010.

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