- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04423822
Stress Test on the Prediction of Cardiovascular Events in a High-risk Firefighter Population (FIRE-PREV)
December 21, 2021 updated by: Centre Hospitalier Universitaire de Saint Etienne
Contributions and Limitations of the Stress Test on the Prediction of Cardiovascular Events in a High-risk Firefighter Population
If the risk of myocardial infarction in activity is widely demonstrated to date for firefighters, and the realization of a stress test in those at high cardiovascular risk included in the practice habits, no study has evaluated the contributions and limits of the realization of a stress test in this specific population of firefighters at high cardiovascular risk for the prediction of cardiovascular events.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The professional practice of firefighting presents risks specific, especially cardiovascular.
In the United States 30% of Firefighter deaths are the result of a myocardial infarction that occurred while on duty.
Certain occupational tasks expose firefighters to a higher risk of myocardial infarction (high physical load, inhalation of products).
There is no recommendation on how to assess cardiovascular risk in French firefighters.
In the absence of consensus, the Loire Departmental Fire and Rescue Service has constructed a scale for collecting cardiovascular risk factors (expert working group) to identify firefighters at high cardiovascular risk.
A maintenance visit (mandatory every two years until the age of 38 and then once a year) is the best way to assess this cardiovascular risk, with a biological assessment and an electrocardiogram after the age of 40.
If cardiovascular risk factors are present and the cardiovascular risk is high, the resting electrocardiogram should be supplemented by an exercise test.
An exercise test can directly or indirectly quantify the endurance capacities of firefighters and reveal cardiac abnormalities sometimes absent at rest.
Half of all myocardial infarctions occur without any prior symptomatology and remain totally asymptomatic, discovered during routine examinations.
If the risk of myocardial infarction in activity is widely demonstrated to date for firefighters, and the realization of a stress test in those at high cardiovascular risk included in the practice habits, no study has evaluated the contributions and limits of the realization of a stress test in this specific population of firefighters at high cardiovascular risk for the prediction of cardiovascular events.
Study Type
Observational
Enrollment (Actual)
94
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
-
-
-
Saint-Étienne, France
- Centre Hospitalier Universitaire
-
-
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
Sampling Method
Probability Sample
Study Population
firefighters with high cardiovascular risk
Description
Inclusion Criteria:
- Any professional or volunteer firefighter with a high cardiovascular risk attached to the Departmental Fire and Rescue Service of the Loire who has carried out an effort test between 2006 and 2014.
- Subject who received informed oral information about the study by telephone and agreed to participate in the study
Exclusion Criteria:
- Subject unable to understand the study
- Subject matter subject to a legal protection measure
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Firefighter
Firefighter with high cardiovascular risk
|
endurance capacity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular morbidity
Time Frame: Between 2006 and 2014
|
determined by occurrence of: Cardiovascular death; Myocardial infarction; stroke; Arteriopathy; Atrial fibrillation
|
Between 2006 and 2014
|
Cardiovascular mortality
Time Frame: Between 2006 and 2014
|
determined by occurrence of: Cardiovascular death; Myocardial infarction; stroke; Arteriopathy; Atrial fibrillation
|
Between 2006 and 2014
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 12, 2021
Primary Completion (Actual)
September 18, 2021
Study Completion (Actual)
September 18, 2021
Study Registration Dates
First Submitted
June 8, 2020
First Submitted That Met QC Criteria
June 8, 2020
First Posted (Actual)
June 9, 2020
Study Record Updates
Last Update Posted (Actual)
January 11, 2022
Last Update Submitted That Met QC Criteria
December 21, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 19CH235
- 2020-A00270-39 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
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