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临床试验/NCT00745446
NCT00745446已完成不适用

The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation

University of Edinburgh2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Forearm blood flow in response to infused intra-arterial vasodilators

研究概览

简要总结

The purpose of this study is to determine whether a retrofit particle trap can reduce the adverse vascular responses to diesel exhaust inhalation

详细描述

18 subjects healthy male volunteers will be recruited at Umeå University. In a randomised, double blind 3 way crossover trial, subjects will be exposed to filtered air, diesel exhaust (300mcg/m3) or filtered diesel exhaust for 1 hour during intermittent exercise.

2 hours following the exposure, thrombogenicity will be assessed using the Badimon chamber - an ex-vivo model of thrombosis formed under constant flow conditions.

Forearm blood flow in response to infused intra-brachial vasodilators will be measured using venous occlusion plethysmography 6 hours after the exposure.

Arterial stiffness will be measured using peripheral arterial applanation tonometry in the hour post-exposure.

Blood samples will be collected at timepoints over the 24 hours after exposure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy male volunteers

排除标准

  • Intercurrent illness
  • Significant occupational exposure to air pollution
  • Regular medication usage

结局指标

主要结局

Forearm blood flow in response to infused intra-arterial vasodilators

时间窗: 6 hours post-exposure

次要结局

  • Arterial stiffness measured by applanation tonometry(In the 1 hour following exposure)
  • Thrombogenicity measured using the Badimon chamber - an ex-vivo model of thrombosis under conditions of continuous flow(2 hours after the exposure)
  • Exhaled nitric oxide - a marker of pulmonary inflammation(1 hour & 6 hours after exposure)
  • Endogenous fibrinolytic capacity - measured as net release of t-PA in response to infused bradykinin(6 hours after exposure)
  • Biochemical markers of systemic inflammation(Baseline, 2, 6 & 24 hours)

研究者

申办方类型
Other

研究点 (2)

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