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

April 29, 2022 updated by: University Hospital, Brest
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France
        • CHRU Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: welder/airport agent
No drug and no placebo were used in this study.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular reactivity
Time Frame: 1 day
Assessement of microvascular reactivity by laser Doppler flowmetry associated to iontophoretic administration of ACh and SNP
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coagulation activation
Time Frame: 1 day
Assessment of markers of blood coagulation
1 day
vascular inflammation
Time Frame: 1 day
Assessment of factors of inflammation
1 day
Impregnation of metals activation
Time Frame: 1 day
Assessment of impregnation factor
1 day
Oxidative stress activation
Time Frame: 1 day
Assessment of markers of oxidative stress
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2017

Primary Completion (Actual)

June 24, 2019

Study Completion (Actual)

June 24, 2019

Study Registration Dates

First Submitted

September 11, 2017

First Submitted That Met QC Criteria

September 11, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 29BRC17.0131 RISCAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Effects of Welding Fumes Components

Clinical Trials on Laser doppler, blood tests, and holter ECG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe