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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281239
Recruitment Status : Terminated (in view of the difficulties of inclusion in this study, it was decided not to extend this period)
First Posted : September 13, 2017
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Effects of Welding Fumes Components Diagnostic Test: Laser doppler, blood tests, and holter ECG Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of the Impact of Welding Fumes on the Arterial System : RISCAS Study
Actual Study Start Date : November 28, 2017
Actual Primary Completion Date : November 28, 2019
Actual Study Completion Date : November 28, 2019

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.




Primary Outcome Measures :
  1. Vascular reactivity [ Time Frame: 1 day ]
    Assessement of microvascular reactivity by laser Doppler flowmetry associated to iontophoretic administration of ACh and SNP


Secondary Outcome Measures :
  1. Coagulation activation [ Time Frame: 1 day ]
    Assessment of markers of blood coagulation

  2. vascular inflammation [ Time Frame: 1 day ]
    Assessment of factors of inflammation

  3. Impregnation of metals activation [ Time Frame: 1 day ]
    Assessment of impregnation factor

  4. Oxidative stress activation [ Time Frame: 1 day ]
    Assessment of markers of oxidative stress



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281239


Locations
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France
CHRU Brest
Brest, France
Sponsors and Collaborators
University Hospital, Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03281239    
Other Study ID Numbers: 29BRC17.0131 RISCAS
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
welder, airport agent, Welding fumes