Angina PectorisNCT00738491
Effects of Ambient Air Pollution Exposure in Patients With Stable Angina Pectoris During Normal Daily Activities
An observational study of Angina Pectoris and Coronary Heart Disease, run by University of Edinburgh at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to identify whether exposure to ambient levels of air pollution during normal daily activities has a functional impact on patients with coronary heart disease Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angina Pectoris, Coronary Heart Disease
- How many people
- 1 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2008to Aug 2013
- Phase
- Observational
- 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
Study population: Patients with stable angina pectoris and documented coronary artery disease
Who may be able to join
- Documented coronary artery disease
- Symptoms of stable angina pectoris
- Positive BRUCE exercise stress test between 3 and 13 minutes
Who cannot join
- History of arrhythmia
- Severe 3 vessel coronary disease or left main stem stenosis that has not been revascularised
- Resting conduction abnormality
- Digoxin therapy
- Uncontrolled hypertension
- Renal or hepatic failure
- Unstable symptoms or acute coronary syndrome within 3 months
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Edinburgh
Edinburgh, Midlothian, EH16 4SB
Imperial College
London, SW3 6LY
About this study
The purpose of this study is to identify whether exposure to ambient levels of air pollution during normal daily activities has a functional impact on patients with coronary heart disease
Read the detailed description
Exposure to air pollution has been shown in epidemiological studies to be closely linked to cardiovascular 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. In controlled exposure studies, we have recently demonstrated that exposure to diesel exhaust causes increased myocardial ischaemia with exercise in patients with asymptomatic coronary artery disease. The mechanism behind this effect is not yet understood, but we have shown that diesel exhaust exposure causes an acute impairment of two important and highly relevant aspects of vascular tone: vasomotor tone and endogenous fibrinolysis. In this study we propose to investigate the effects of exposure to ambient levels of air pollution on patients with stable, symptomatic angina pectoris, during their daily lives.
- Conditions
- Angina Pectoris, Coronary Heart Disease
- Keywords
- Angina pectoris, Exercise capacity, Myocardial ischaemia, Air pollution
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with stable angina pectoris and documented coronary heart disease recruited in Edinburgh | |
| 2 | Patients with stable angina pectoris and documented coronary heart disease recruited in London |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of angina pectoris - assessed by symptom diary and reliever medication usage
Measured: Throughout study period
Secondary outcomes (6)
Myocardial ischaemic burden - assessed using 12-lead continuous Holter ECG monitoring
Measured: Throughout study period
Time to 1mm ST segment depression during standard BRUCE exercise stress testing
Measured: At the end of the study period
Total exercise capacity - measured using GPS tracking of activity completed
Measured: Throughout study period
Exercise capacity - determined by standard BRUCE exercise stress testing
Measured: Immediately after study period
Ambulatory blood pressure
Measured: Throughout study period
Biochemical evidence of myocardial ischaemia - highly sensitive troponin, ischaemically modified albumin and fatty acid binding protein
Measured: Before and after study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: Study performed in alternative location (Beijing China)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Principal investigator, Jeremy Langrish, University of Edinburgh
- Investigators
- Jeremy P Langrish, MB BCh, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738491
- Sponsor's protocol ID
- 08/S1101/6
- Status last verified
- Dec 2014
- First submitted
- 19 Aug 2008
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
McCreanor J, Cullinan P, Nieuwenhuijsen MJ, Stewart-Evans J, Malliarou E, Jarup L, Harrington R, Svartengren M, Han IK, Ohman-Strickland P, Chung KF, Zhang J. Respiratory effects of exposure to diesel traffic in persons with asthma. N Engl J Med. 2007 Dec 6;357(23):2348-58. doi: 10.1056/NEJMoa071535.
PubMed 18057337Mills 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 17855668Tornqvist H, Mills NL, Gonzalez M, Miller MR, Robinson SD, Megson IL, Macnee W, Donaldson K, Soderberg S, Newby DE, Sandstrom T, Blomberg A. Persistent endothelial dysfunction in humans after diesel exhaust inhalation. Am J Respir Crit Care Med. 2007 Aug 15;176(4):395-400. doi: 10.1164/rccm.200606-872OC. Epub 2007 Apr 19.
PubMed 17446340Mills NL, Tornqvist H, Robinson SD, Gonzalez M, Darnley K, MacNee W, Boon NA, Donaldson K, Blomberg A, Sandstrom T, Newby DE. Diesel exhaust inhalation causes vascular dysfunction and impaired endogenous fibrinolysis. Circulation. 2005 Dec 20;112(25):3930-6. doi: 10.1161/CIRCULATIONAHA.105.588962.
PubMed 16365212
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ambient Air Pollution Exposure in Patients With Stable Angina Pectoris During Normal Daily Activities
- ClinicalTrials.gov ID
- NCT00738491
- Acronym / sponsor ID
- 08/S1101/6
- Conditions
- Angina Pectoris, Coronary Heart Disease
- Keywords
- Angina pectoris, Exercise capacity, Myocardial ischaemia, Air pollution
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study performed in alternative location (Beijing China)
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- Aug 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify whether exposure to ambient levels of air pollution during normal daily activities has a functional impact on patients with coronary heart disease
Detailed description
Exposure to air pollution has been shown in epidemiological studies to be closely linked to cardiovascular 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. In controlled exposure studies, we have recently demonstrated that exposure to diesel exhaust causes increased myocardial ischaemia with exercise in patients with asymptomatic coronary artery disease. The mechanism behind this effect is not yet understood, but we have shown that diesel exhaust exposure causes an acute impairment of two important and highly relevant aspects of vascular tone: vasomotor tone and endogenous fibrinolysis. In this study we propose to investigate the effects of exposure to ambient levels of air pollution on patients with stable, symptomatic angina pectoris, during their daily lives.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with stable angina pectoris and documented coronary heart disease recruited in Edinburgh |
| 2 | – | –Patients with stable angina pectoris and documented coronary heart disease recruited in London |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with stable angina pectoris and documented coronary artery disease
Key inclusion criteria (3 listed)
- Documented coronary artery disease
- Symptoms of stable angina pectoris
- Positive BRUCE exercise stress test between 3 and 13 minutes
Key exclusion criteria (7 listed)
- History of arrhythmia
- Severe 3 vessel coronary disease or left main stem stenosis that has not been revascularised
- Resting conduction abnormality
- Digoxin therapy
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptoms of angina pectoris - assessed by symptom diary and reliever medication usage
Time frame: Throughout study period
6 secondary outcomes
Myocardial ischaemic burden - assessed using 12-lead continuous Holter ECG monitoring
Time frame: Throughout study period
Time to 1mm ST segment depression during standard BRUCE exercise stress testing
Time frame: At the end of the study period
Total exercise capacity - measured using GPS tracking of activity completed
Time frame: Throughout study period
Exercise capacity - determined by standard BRUCE exercise stress testing
Time frame: Immediately after study period
Ambulatory blood pressure
Time frame: Throughout study period
Biochemical evidence of myocardial ischaemia - highly sensitive troponin, ischaemically modified albumin and fatty acid binding protein
Time frame: Before and after study period
Results and safety
The study was stopped early (reason given: Study performed in alternative location (Beijing China)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Background: PubMed 18057337McCreanor J, Cullinan P, Nieuwenhuijsen MJ, Stewart-Evans J, Malliarou E, Jarup L, Harrington R, Svartengren M, Han IK, Ohman-Strickland P, Chung KF, Zhang J. Respiratory effects of exposure to diesel traffic in persons with asthma. N Engl J Med. 2007 Dec 6;357(23):2348-58. doi: 10.1056/NEJMoa071535.
- Background: PubMed 17855668Mills 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.
- Background: PubMed 17446340Tornqvist H, Mills NL, Gonzalez M, Miller MR, Robinson SD, Megson IL, Macnee W, Donaldson K, Soderberg S, Newby DE, Sandstrom T, Blomberg A. Persistent endothelial dysfunction in humans after diesel exhaust inhalation. Am J Respir Crit Care Med. 2007 Aug 15;176(4):395-400. doi: 10.1164/rccm.200606-872OC. Epub 2007 Apr 19.
- Background: PubMed 16365212Mills NL, Tornqvist H, Robinson SD, Gonzalez M, Darnley K, MacNee W, Boon NA, Donaldson K, Blomberg A, Sandstrom T, Newby DE. Diesel exhaust inhalation causes vascular dysfunction and impaired endogenous fibrinolysis. Circulation. 2005 Dec 20;112(25):3930-6. doi: 10.1161/CIRCULATIONAHA.105.588962.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy P Langrish, MB BCh principal investigator
University of Edinburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina Pectoris and Coronary Heart Disease, run by University of Edinburgh at 2 sites in United Kingdom.
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 7 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: stopped early, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 was stopped early (reason given: Study performed in alternative location (Beijing China)). Results are not available in the source record.
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?
Symptoms of angina pectoris - assessed by symptom diary and reliever medication usage (time frame: Throughout study 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 NCT00738491, which also lists 4 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 2 Dec 2014.