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
|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)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||The Effects of Air Pollution on Vascular and Endogenous Fibrinolytic Function in Patients With Coronary Heart Disease|
|Study Start Date :||April 2006|
|Estimated Study Completion Date :||June 2006|
- Exercise induced myocardial ischemia
- Vascular vasomotor function
- Endogenous fibrinolytic function
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
|Umeå, Västerbotten, Sweden, 901 85|
|Principal Investigator:||David E Newby, MD||The University of Edinburgh|
|Principal Investigator:||Thomas Sandstrom, MD||Umeå University|