<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03281239</url>
  </required_header>
  <id_info>
    <org_study_id>29BRC17.0131 RISCAS</org_study_id>
    <nct_id>NCT03281239</nct_id>
  </id_info>
  <brief_title>Study of the Impact of Welding Fumes on the Arterial System : RISCAS Study</brief_title>
  <acronym>RISCAS</acronym>
  <official_title>Study of the Impact of Welding Fumes on the Arterial System : RISCAS Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Metals and oxydes are found in welding fumes and are thought to participate in increasing&#xD;
      cardiovascular risk in exposed workers. Investigators aimed to evaluate the impact of this&#xD;
      occupational exposure on cardiovascular system in a highly exposed population, ship repairing&#xD;
      welders and to compare this population to paired controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In an exposed-non-exposed study, investigators will include 30 welders and 30 airport runway&#xD;
      agents for control. As part of cardiovascular independent risk factors, microvascular&#xD;
      endothelial function will be evaluated directly by laser Doppler flowmetry. Blood samples&#xD;
      will be also collected and circulating markers of endothelial function (VW factor,&#xD;
      E-selectin, VCAM, ICAM, circulating DNA), inflammation (CRP, IL-1β, IL-8, TNFα, IL-10),&#xD;
      platelet activation (procoagulant microparticles, thrombin generation, fibin monomer) will be&#xD;
      measured. A complete clinical and functional cardiovascular status will be documented in&#xD;
      every participant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to the difficulties of inclusion, it was decided not to extend this period&#xD;
  </why_stopped>
  <start_date type="Actual">November 28, 2017</start_date>
  <completion_date type="Actual">June 24, 2019</completion_date>
  <primary_completion_date type="Actual">June 24, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vascular reactivity</measure>
    <time_frame>1 day</time_frame>
    <description>Assessement of microvascular reactivity by laser Doppler flowmetry associated to iontophoretic administration of ACh and SNP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Coagulation activation</measure>
    <time_frame>1 day</time_frame>
    <description>Assessment of markers of blood coagulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vascular inflammation</measure>
    <time_frame>1 day</time_frame>
    <description>Assessment of factors of inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impregnation of metals activation</measure>
    <time_frame>1 day</time_frame>
    <description>Assessment of impregnation factor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative stress activation</measure>
    <time_frame>1 day</time_frame>
    <description>Assessment of markers of oxidative stress</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Effects of Welding Fumes Components</condition>
  <arm_group>
    <arm_group_label>welder/airport agent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No drug and no placebo were used in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Laser doppler, blood tests, and holter ECG</intervention_name>
    <description>Diagnostic tests :&#xD;
laser doppler&#xD;
blood tests&#xD;
Holter ECG. No drug and no placebo were used in this arm.</description>
    <arm_group_label>welder/airport agent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female ≥ 18 years&#xD;
&#xD;
          -  Employee performing welding or airport operations&#xD;
&#xD;
          -  free, informed and written consent&#xD;
&#xD;
          -  Being affiliated to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking cardiovascular medications which modify endothelial function and / or&#xD;
             coagulation (antiplatelet, antihypertensive, cardiotropic).&#xD;
&#xD;
          -  People with a history of ischemic cardiovascular disease, thrombotic disease, chronic&#xD;
             inflammatory disease&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  People with health status would be likely, in the baseline state, to have parameters&#xD;
             studied in the study disrupted.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHRU Brest</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>April 29, 2022</last_update_submitted>
  <last_update_submitted_qc>April 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>welder, airport agent, Welding fumes</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03281239
org study id: 29BRC17.0131 RISCAS
nct id: NCT03281239
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Vascular reactivity
time frame: 1 day
description: Assessement of microvascular reactivity by laser Doppler flowmetry associated to iontophoretic administration of ACh and SNP
measure: Coagulation activation
time frame: 1 day
description: Assessment of markers of blood coagulation
measure: vascular inflammation
time frame: 1 day
description: Assessment of factors of inflammation
measure: Impregnation of metals activation
time frame: 1 day
description: Assessment of impregnation factor
measure: Oxidative stress activation
time frame: 1 day
description: Assessment of markers of oxidative stress
arm group label: welder/airport agent
arm group type: Experimental
description: No drug and no placebo were used in this study.
intervention type: Diagnostic Test
intervention name: Laser doppler, blood tests, and holter ECG
description: Diagnostic tests :
laser doppler
blood tests
Holter ECG. No drug and no placebo were used in this arm.
arm group label: welder/airport agent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor