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临床试验/NCT00437138
NCT00437138已完成早期 1 期

The Effects of Air Pollution on Vascular and Endogenous Fibrinolytic Function in Patients With Coronary Heart Disease

University of Edinburgh2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年4月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
20
试验地点
2
主要终点
Exercise induced myocardial ischemia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Previous myocardial infarction (>6 months previously) treated by primary angioplasty and stenting
  • On standard secondary preventative therapy

排除标准

  • 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
  • Inter-current illness

结局指标

主要结局

Exercise induced myocardial ischemia

Vascular vasomotor function

Endogenous fibrinolytic function

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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