Controlled Exposures to Air Pollution in Patients With Coronary Heart Disease
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ClinicalTrials.gov Identifier: NCT00437138 |
Recruitment Status :
Completed
First Posted : February 19, 2007
Last Update Posted : February 19, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Heart Disease | Behavioral: Exposure to dilute diesel exhaust (300µg/m3) or filtered air | Early Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | The Effects of Air Pollution on Vascular and Endogenous Fibrinolytic Function in Patients With Coronary Heart Disease |
Study Start Date : | April 2006 |
Study Completion Date : | June 2006 |

- Exercise induced myocardial ischemia
- Vascular vasomotor function
- Endogenous fibrinolytic function

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Previous myocardial infarction (>6 months previously) treated by primary angioplasty and stenting
- On standard secondary preventative therapy
Exclusion Criteria:
- 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)
- Occupational exposure to air pollution
- Current smokers
- Asthma
- Inter-current illness

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437138
Sweden | |
Umeå University | |
Umeå, Västerbotten, Sweden, 901 85 |
Principal Investigator: | David E Newby, MD | University of Edinburgh | |
Principal Investigator: | Thomas Sandstrom, MD | Umeå University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00437138 |
Other Study ID Numbers: |
RG/05/003 DISARM 2 |
First Posted: | February 19, 2007 Key Record Dates |
Last Update Posted: | February 19, 2007 |
Last Verified: | February 2007 |
Air pollution Myocardial ischemia Endothelium |
Fibrinolysis Pathophysiology Diesel exhaust |
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia |
Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |