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

Not Applicable

Terminated

• Conditions: Effects of Welding Fumes Components
• Interventions: Diagnostic Test: Laser doppler, blood tests, and holter ECG

• Registration Number: NCT03281239
• Lead Sponsor: University Hospital, Brest

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-13
• Study Start: 2017-11-28
• Primary Completion: 2019-06-24
• Study Completion: 2019-06-24
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
welder/airport agent	Laser doppler, blood tests, and holter ECG	No drug and no placebo were used in this study.

Primary Outcome Measures

Name	Time	Method
Vascular reactivity	1 day	Assessement of microvascular reactivity by laser Doppler flowmetry associated to iontophoretic administration of ACh and SNP

Secondary Outcome Measures

Name	Time	Method
vascular inflammation	1 day	Assessment of factors of inflammation
Impregnation of metals activation	1 day	Assessment of impregnation factor
Coagulation activation	1 day	Assessment of markers of blood coagulation
Oxidative stress activation	1 day	Assessment of markers of oxidative stress

Trial Locations

Locations (1)

CHRU Brest; 🇫🇷 Brest, France