Symptoms of Acute Coronary Syndrome in Medical Regulation | NCT05902130

Studies
Symptoms of Acute Coronary Syndrome in Medical Regulation

NCT05902130

Sponsor

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Last Update Posted

Dec 26, 2023Actual

Enrollment

208Actual

Phase

Not provided

Conditions

Acute Coronary Syndrome

Interventions

symptoms of a myocardial infarction

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Oct 1, 2023Actual

Completion Date

Oct 1, 2023Actual

First Submitted Date

May 22, 2023

First Submission Date that Met QC Criteria

Jun 5, 2023

First Posted Date

Jun 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2023

Last Update Posted Date

Dec 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

208Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
symptoms of a myocardial infarction	Other	Analysis of the differences in symptoms of a myocardial infarction between a man and a woman

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Delay between the call to the emergency center and the first electrocardiogram	Delay (hours:minutes)	At hospital discharge, an average of 2 hours
Dispatch of a medical ambulance (Y/N)	Number (%)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laure ABENSUR VUILLAUME, MD, PhD	CHR Metz Thionville Hopital de Mercy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHR Metz-Thionville/Hopital de Mercy		Metz		57085	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

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Browse Branches

Not provided