Coronary Heart DiseaseEarly Phase 1NCT00437138
Controlled Exposures to Air Pollution in Patients With Coronary Heart Disease
A Early Phase 1 study testing Exposure to dilute diesel exhaust (300µg/m3) or filtered air in people with Coronary Heart Disease, run by University of Edinburgh at 1 site in Sweden.
Trial summary
Air pollution is a major cause of cardiovascular morbidity and mortality. The components of air pollution responsible and the mechanisms through which they might mediate these harmful effects remain only partially understood. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Exposure to dilute diesel exhaust (300µg/m3) or filtered air
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2006to Jun 2006
- Phase
- Early Phase 1
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous myocardial infarction (>6 months previously) treated by primary angioplasty and stenting
- On standard secondary preventative therapy
Who cannot join
- Angina pectoris (Canadian Cardiovascular Society grade ≥2)
- History of arrhythmia
- Diabetes mellitus
- Uncontrolled hypertension
- Renal or hepatic failure
- Unstable coronary disease (acute coronary syndrome or unstable symptoms within 3 months)
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- Occupational exposure to air pollution
- Current smokers
- Asthma
- Inter-current illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Air Pollution on Vascular and Endogenous Fibrinolytic Function in Patients With Coronary Heart Disease
Air pollution is a major cause of cardiovascular morbidity and mortality. The components of air pollution responsible and the mechanisms through which they might mediate these harmful effects remain only partially understood. We hypothesise that these adverse effects are mediated by combustion derived air pollutants and that even a brief exposure will effect heart and blood vessel function. We assess the effect of dilute diesel exhaust inhalation at levels encountered in urban road traffic on heart and blood vessel function in patients with stable coronary heart disease.
Read the detailed description
Observational studies suggest that exposure to air pollution may worsen symptoms of angina and trigger acute myocardial infarction. These findings are limited by imprecision in the measurement of pollution exposure, the effect of potential confounding environmental and social factors, and the lack of mechanistic data. Controlled exposures of air pollutants can help to address these shortcomings by providing a precisely defined exposure in a regulated environment that facilitates investigation with validated biomarkers and surrogate measures of cardiovascular health. Using a carefully characterised exposure system, we have previously shown in healthy volunteers that exposure to dilute diesel exhaust causes lung inflammation, depletion of airway antioxidant defences, and impairment of vascular and fibrinolytic function. To date, there have been no controlled exposures in patients with coronary heart disease: an important population who may be particularly susceptible to the adverse cardiovascular effects of air pollution.
In a double blind randomized cross-over study, 20 patients with prior myocardial infarction will be exposed to dilute diesel exhaust (300µg/m3) or filtered air during periods of rest and moderate exercise in a controlled exposure facility. During the exposure, myocardial ischemia will be quantified by ST-segment analysis using continuous 12-lead electrocardiography. Six hours following exposure, vascular vasomotor and fibrinolytic function will be assessed by means of intra-arterial agonist infusions.
- Conditions
- Coronary Heart Disease
- Being tested
- Exposure to dilute diesel exhaust (300µg/m3) or filtered air
- Keywords
- Air pollution, Myocardial ischemia, Endothelium, Fibrinolysis, Pathophysiology, Diesel exhaust
- Medical subject headings
- Coronary Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to dilute diesel exhaust (300µg/m3) or filtered airBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise induced myocardial ischemia
Vascular vasomotor function
Endogenous fibrinolytic function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startApr 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University
- Investigators
- David E Newby, MD, Principal investigator, University of EdinburghThomas Sandstrom, MD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437138
- Sponsor's protocol ID
- RG/05/003 DISARM 2
- Status last verified
- Feb 2007
- First submitted
- 16 Feb 2007
- Last updated
- 19 Feb 2007
- Results posted
- No
Publications
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 24667535Mills 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