Controlled Exposures to Air Pollution in Patients With Coronary Heart Disease
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Heart Disease |
Behavioral: Exposure to dilute diesel exhaust (300µg/m3) or filtered air |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | The Effects of Air Pollution on Vascular and Endogenous Fibrinolytic Function in Patients With Coronary Heart Disease |
- Exercise induced myocardial ischemia
- Vascular vasomotor function
- Endogenous fibrinolytic function
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | June 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Sweden | |
| Umeå University | |
| Umeå, Västerbotten, Sweden, 901 85 | |
| Principal Investigator: | David E Newby, MD | The University of Edinburgh |
| Principal Investigator: | Thomas Sandstrom, MD | Umeå University |
More Information
Additional Information:
No publications provided by University of Edinburgh
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00437138 History of Changes |
| Other Study ID Numbers: | RG/05/003 DISARM 2 |
| Study First Received: | February 16, 2007 |
| Last Updated: | February 16, 2007 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by University of Edinburgh:
|
Air pollution Myocardial ischemia Endothelium |
Fibrinolysis Pathophysiology Diesel exhaust |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013