NCT05902130

Brief Summary

The main objective was to analyze the impact of the gender of the attending physician in the differences in the management of ST+ ACS between men and women. This study will be conducted in partnership with the interventional cardiology team of the CHR Metz-Thionville and SAMU (emergency call center) of Moselle, which has a detailed registry of coronary angiographies at the center. A retrospective observational study will be carried out over a "typical" period outside of covid at the CHR Metz Mercy (2021-2022) based on coronary angiographies performed in the context of ST+ ACS at the CHR of patients referred by the center 15. The patient's medical record will be analyzed, going back to his call to the 15 via tape listening. The number of subjects required being calculated at 104 men and 104 women, these patients will be selected from the database of our cardiologist colleagues and we will match one man to one woman by comparing the delays of several items (1st medical contact, time of 1st ECG, medicalization or not, delay of call to the cardiologist, delay of coronary angiography...) according to the sex of the regulator. The consequences of a difference in management will be also evaluated by analyzing in-hospital mortality, mortality at 30 days of management, and functional sequelae at discharge (grades of dyspnea, disturbance of myocardial contractility, LVEF at discharge). This study based on the differences in questioning according to the gender of the regulating physician would allow better identification of the factors that increase the delay in the management of ST+ ACS in women, and to find avenues of correction in order to limit the loss of opportunity for patients. The patients included who are still alive will receive a notification of non-objection by mail.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

May 22, 2023

Last Update Submit

December 22, 2023

Conditions

Keywords

acute coronary syndromeout-hospital caremedical regulation

Outcome Measures

Primary Outcomes (1)

  • Delay between the call to the emergency center and the first contact with a physician

    Delay (minutes:seconds)

    End of the call to the emergency center, less than 10 min

Secondary Outcomes (6)

  • Delay between the call to the emergency center and the first electrocardiogram

    At hospital discharge, an average of 2 hours

  • Dispatch of a medical ambulance (Y/N)

    End of the call to the emergency center, an average of 20 min

  • Delay between the call to the emergency center and the first coronary angiography

    At hospital discharge, an average of 2 hours

  • In-hospital mortality

    30 days after the call to emergency center

  • Day 30 mortality

    30 days after the call to emergency center

  • +1 more secondary outcomes

Interventions

Analysis of the differences in symptoms of a myocardial infarction between a man and a woman

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The cohort includes patients admitted for coronary angiography at the Mercy hospital center in 2021-2022, having had a confirmed diagnosis of ACS ST+ and who made an initial call to the Moselle SAMU.

You may qualify if:

  • patient with emergency coronary angiography for ST+ ACS
  • having made a call to the Emergency Center for the same reason

You may not qualify if:

  • non-real ST+ ACS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Laure ABENSUR VUILLAUME, MD, PhD

    CHR Metz Thionville Hopital de Mercy

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 13, 2023

Study Start

January 1, 2023

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

December 26, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations