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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05902130
Other study ID # 2023-03Obs-CHRMT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date October 1, 2023

Study information

Verified date December 2023
Source Centre Hospitalier Régional Metz-Thionville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 208
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patient with emergency coronary angiography for ST+ ACS - having made a call to the Emergency Center for the same reason Exclusion Criteria: - non-real ST+ ACS

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHR Metz-Thionville/Hopital de Mercy Metz

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Delay between the call to the emergency center and the first electrocardiogram Delay (hours:minutes) At hospital discharge, an average of 2 hours
Secondary Dispatch of a medical ambulance (Y/N) Number (%) End of the call to the emergency center, an average of 20 min
Secondary Delay between the call to the emergency center and the first coronary angiography Delay (minutes) At hospital discharge, an average of 2 hours
Secondary In-hospital mortality Number (%) 30 days after the call to emergency center
Secondary Day 30 mortality Number (%) 30 days after the call to emergency center
Secondary Left Ventricular Ejection Fraction Percentage At hospital discharge, less than 30 days
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