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

NCT ID: NCT03281239

Last Updated: 2022-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2019-06-24

Brief Summary

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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

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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.

Conditions

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Effects of Welding Fumes Components

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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welder/airport agent

No drug and no placebo were used in this study.

Group Type EXPERIMENTAL

Laser doppler, blood tests, and holter ECG

Intervention Type DIAGNOSTIC_TEST

Diagnostic tests :

* laser doppler
* blood tests
* Holter ECG. No drug and no placebo were used in this arm.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU Brest

Brest, , France

Site Status

Countries

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France

Other Identifiers

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29BRC17.0131 RISCAS

Identifier Type: -

Identifier Source: org_study_id

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