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临床试验/NCT03281239
NCT03281239终止不适用

Study of the Impact of Welding Fumes on the Arterial System : RISCAS Study

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2017年11月28日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
51
试验地点
1
主要终点
Vascular reactivity

研究概览

简要总结

Metals and oxydes are found in welding fumes and are thought to participate in increasing cardiovascular risk in exposed workers. Investigators aimed to evaluate the impact of this occupational exposure on cardiovascular system in a highly exposed population, ship repairing welders and to compare this population to paired controls.

详细描述

In an exposed-non-exposed study, investigators will include 30 welders and 30 airport runway agents for control. As part of cardiovascular independent risk factors, microvascular endothelial function will be evaluated directly by laser Doppler flowmetry. Blood samples will be also collected and circulating markers of endothelial function (VW factor, E-selectin, VCAM, ICAM, circulating DNA), inflammation (CRP, IL-1β, IL-8, TNFα, IL-10), platelet activation (procoagulant microparticles, thrombin generation, fibin monomer) will be measured. A complete clinical and functional cardiovascular status will be documented in every participant.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Male or Female ≥ 18 years
  • Employee performing welding or airport operations
  • free, informed and written consent
  • Being affiliated to a social security system

排除标准

  • Taking cardiovascular medications which modify endothelial function and / or coagulation (antiplatelet, antihypertensive, cardiotropic).
  • People with a history of ischemic cardiovascular disease, thrombotic disease, chronic inflammatory disease
  • Pregnant women
  • People with health status would be likely, in the baseline state, to have parameters studied in the study disrupted.

结局指标

主要结局

Vascular reactivity

时间窗: 1 day

Assessement of microvascular reactivity by laser Doppler flowmetry associated to iontophoretic administration of ACh and SNP

次要结局

  • vascular inflammation(1 day)
  • Impregnation of metals activation(1 day)
  • Coagulation activation(1 day)
  • Oxidative stress activation(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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