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

Effects of Welding Fumes Components Clinical Trial

— RISCAS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03281239
• Other study ID #: 29BRC17.0131 RISCAS
• Status: Terminated
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: June 24, 2019

Study information

• Verified date: April 2022
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: June 24, 2019
• Est. primary completion date: June 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Effects of Welding Fumes Components

Intervention

Diagnostic Test:
• Laser doppler, blood tests, and holter ECG
Diagnostic tests : laser doppler blood tests Holter ECG. No drug and no placebo were used in this arm.

Locations

Country	Name	City	State
France	CHRU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular reactivity	Assessement of microvascular reactivity by laser Doppler flowmetry associated to iontophoretic administration of ACh and SNP	1 day
Secondary	Coagulation activation	Assessment of markers of blood coagulation	1 day
Secondary	vascular inflammation	Assessment of factors of inflammation	1 day
Secondary	Impregnation of metals activation	Assessment of impregnation factor	1 day
Secondary	Oxidative stress activation	Assessment of markers of oxidative stress	1 day