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临床试验/NCT04098536
NCT04098536招募中不适用

Acute Exposure to Diesel: Prolong Effects on Inflammation and Vasculature

University of Athens4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
4
主要终点
Endothelial function assesment

研究概览

简要总结

Cross-over double-blind study. Healthy subjects will be exposed to diesel exhaust fumes and/or filtered air during a 2-hour session. Several parameters will be assesed i.e. endothelial function will be assessed with flow mediated dilation (FMD) techniques, arterial stiffness with pulse wave velocity (PWV) and reflected waves with augmentation index (AIx). C reactive protein (CRP), fibrinogen, protein C levels and protein S activity will be also measured. Heart rate variability and standard deviation of normal to normal intervals R-R intervals (SDNN) will be used to assess sympathetic activity. Measurements were assessed before, 2 and 24 hours after diesel exposure.

详细描述

Introduction Diesel and its products represent one of the most common pollutants affecting people living in urban and rural areas of the world. The majority of patients attending emergency departments are likely to have been subjected to chronic exposure to diesel engine exhaust fumes particularly those living in proximity to busy city roads and highways. Diesel exhaust fumes are considered to contribute to over 50% of atmospheric particles with a mass of less than 10 μM (PM10) average aerodynamic diameter, which is responsible for air pollution. For fine particle matter lower than 2.5 μM (PM2.5) and extremely small particles below 0.1 μM in diameter, the contribution to air pollution is much greater. These particles are small enough to be inhaled and deposited in the lungs where they can exert deleterious effects.

In Europe and Japan, epidemiological studies have demonstrated high rates of cardiovascular morbidity, as well as acute and chronic respiratory disease, following occupational exposure to diesel exhaust fumes. Experimental animal studies have also shown that exposure to diluted diesel engine emission impairs left ventricle systolic performance, sympathetic drive, fibrosis/fibrinolysis and accelerates atherosclerosis. Epidemiological studies and experimental animal models are, however, rather imprecise regarding the mechanisms responsible for these effects and the clinical impact of chronic diesel exhaust fumes exposure. Moreover, although a relationship has been documented between acute coronary syndromes (ACS) and acute exposure to diesel engine exhaust fumes, it is not known whether relatively short-term exposure can cause prolonged inflammatory responses and/or affect endothelial function and vessel wall properties in such a way as to potentially promote the development of atherosclerotic changes.

The purpose of this study is to assess the impact of short-term exposure to Diesel exhaust fumes on arterial elasticity, vascular function and inflammatory biomarkers.

Methods Study population Volunteers will be included in this randomized, double blind, crossover study All volunteers who qualified for study entry will be free of cardiovascular disease, hypertension, diabetes mellitus, pulmonary disease and acute inflammatory or chronic diseases. Subjects who will be found to have an abnormal baseline 12-lead electrocardiogram and/or impaired respiratory function tests will be excluded from the study.

Individuals taking cardiovascular medications, antioxidant or vitamin supplementation, oral contraceptives or anti-inflammatory agents during the two months prior to inclusion in the study will be excluded.

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 (Participant, Investigator)

盲法说明

Double blind

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects

排除标准

  • Chronic diseases Cardiovascular diseases Respiratory diseases Pregnacy

研究组 & 干预措施

Diesel Exposure

Experimental

干预措施: Diesel exhaust (Behavioral)

Filtered Air Exposure

Placebo Comparator

干预措施: Diesel exhaust (Behavioral)

结局指标

主要结局

Endothelial function assesment

时间窗: 24 hours

The following outcome will be evaluated Changes over time of : Flow mediated dilation (FMD) mesured in the branchial artery with ultrasound. Units %

Arterial Stifness

时间窗: 24 hours

The following outcome will be evaluated Changes over time of : Carotid-femoral pulse wave velocity (PWV), measured non invasively Units: m/sec

次要结局

  • Sympathetid Activity(24 hours)
  • Inflammation(24 hours)

研究者

发起方
University of Athens
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dimitris Tousoulis

Professor Dimitris Tousoulis

University of Athens

研究点 (4)

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