Effects of Welding Fumes ComponentsRISCASNCT03281239
Study of the Impact of Welding Fumes on the Arterial System : RISCAS Study
A study testing Laser doppler, blood tests, and holter ECG in people with Effects of Welding Fumes Components, run by University Hospital, Brest at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Effects of Welding Fumes Components
- What is being tested?
- Laser doppler, blood tests, and holter ECG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2017to 24 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female ≥ 18 years
- Employee performing welding or airport operations
- free, informed and written consent
- Being affiliated to a social security system
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Effects of Welding Fumes Components
- Being tested
- Laser doppler, blood tests, and holter ECG
- Keywords
- welder, airport agent, Welding fumes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser doppler, blood tests, and holter ECGDiagnostic test
Diagnostic tests :
- laser doppler
- blood tests
- Holter ECG. No drug and no placebo were used in this arm.
| Study group | Role | What they receive |
|---|---|---|
| welder/airport agent | Experimental | No drug and no placebo were used in this study. Receives: Diagnostic Test: Laser doppler, blood tests, and holter ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular reactivity
Assessement of microvascular reactivity by laser Doppler flowmetry associated to iontophoretic administration of ACh and SNP
Measured: 1 day
Secondary outcomes (4)
Coagulation activation
Assessment of markers of blood coagulation
Measured: 1 day
vascular inflammation
Assessment of factors of inflammation
Measured: 1 day
Impregnation of metals activation
Assessment of impregnation factor
Measured: 1 day
Oxidative stress activation
Assessment of markers of oxidative stress
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start28 Nov 2017
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
Why it stopped: Due to the difficulties of inclusion, it was decided not to extend this period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Welding Fumes ComponentsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281239
- Sponsor's protocol ID
- 29BRC17.0131 RISCAS
- Acronym
- RISCAS
- Status last verified
- Apr 2022
- First submitted
- 11 Sep 2017
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Welding Fumes on the Arterial System : RISCAS Study
- ClinicalTrials.gov ID
- NCT03281239
- Acronym / sponsor ID
- RISCAS / 29BRC17.0131 RISCAS
- Conditions
- Effects of Welding Fumes Components
- Keywords
- welder, airport agent, Welding fumes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the difficulties of inclusion, it was decided not to extend this period
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| welder/airport agent | Experimental | Diagnostic Test: Laser doppler, blood tests, and holter ECGNo drug and no placebo were used in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female ≥ 18 years
- Employee performing welding or airport operations
- free, informed and written consent
- Being affiliated to a social security system
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser doppler, blood tests, and holter ECGDiagnostic tests : * laser doppler * blood tests * Holter ECG. No drug and no placebo were used in this arm. | Diagnostic test | welder/airport agent |
Primary outcome
Vascular reactivity
Time frame: 1 day
Assessement of microvascular reactivity by laser Doppler flowmetry associated to iontophoretic administration of ACh and SNP
4 secondary outcomes
Coagulation activation
Time frame: 1 day
vascular inflammation
Time frame: 1 day
Impregnation of metals activation
Time frame: 1 day
Oxidative stress activation
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Due to the difficulties of inclusion, it was decided not to extend this period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser doppler, blood tests, and holter ECG in people with Effects of Welding Fumes Components, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to the difficulties of inclusion, it was decided not to extend this period). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular reactivity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.