NCT04423822

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

January 12, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2021

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

8 months

First QC Date

June 8, 2020

Last Update Submit

December 21, 2021

Conditions

High Cardiovascular RiskFirefighter

Keywords

firefighterhigh cardiovascular riskstress tests

Outcome Measures

Primary Outcomes (2)

  • Cardiovascular morbidity

    determined by occurrence of: Cardiovascular death; Myocardial infarction; stroke; Arteriopathy; Atrial fibrillation

    Between 2006 and 2014

  • Cardiovascular mortality

    determined by occurrence of: Cardiovascular death; Myocardial infarction; stroke; Arteriopathy; Atrial fibrillation

    Between 2006 and 2014

Study Arms (1)

Firefighter

Firefighter with high cardiovascular risk

Other: stress test

Interventions

stress testOTHER

endurance capacity

Firefighter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

firefighters with high cardiovascular risk

You may qualify if:

  • 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

You may not qualify if:

  • Subject unable to understand the study
  • Subject matter subject to a legal protection measure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire

Saint-Etienne, France

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • David HUPIN, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 9, 2020

Study Start

January 12, 2021

Primary Completion

September 18, 2021

Study Completion

September 18, 2021

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)