Acute Coronary SyndromeSCAST+NCT05902130
Symptoms of Acute Coronary Syndrome in Medical Regulation
An observational study of Acute Coronary Syndrome, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- symptoms of a myocardial infarction
- How many people
- 208 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older 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.
Who may be able to join
- patient with emergency coronary angiography for ST+ ACS
- having made a call to the Emergency Center for the same reason
Who cannot join
- non-real ST+ ACS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Symptoms of Acute Coronary Syndrome in Medical Regulation: a Retrospective Study
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.
Read more
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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- symptoms of a myocardial infarction
- Keywords
- acute coronary syndrome, out-hospital care, medical regulation
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
symptoms of a myocardial infarctionOther
Analysis of the differences in symptoms of a myocardial infarction between a man and a woman
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay between the call to the emergency center and the first contact with a physician
Delay (minutes:seconds)
Measured: 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
Delay (hours:minutes)
Measured: At hospital discharge, an average of 2 hours
Dispatch of a medical ambulance (Y/N)
Number (%)
Measured: 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
Delay (minutes)
Measured: At hospital discharge, an average of 2 hours
In-hospital mortality
Number (%)
Measured: 30 days after the call to emergency center
Day 30 mortality
Number (%)
Measured: 30 days after the call to emergency center
Left Ventricular Ejection Fraction
Percentage
Measured: At hospital discharge, less than 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start1 Jan 2023
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure ABENSUR VUILLAUME, MD, PhD, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902130
- Sponsor's protocol ID
- 2023-03Obs-CHRMT
- Acronym
- SCAST+
- Status last verified
- Dec 2023
- First submitted
- 22 May 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms of Acute Coronary Syndrome in Medical Regulation: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05902130
- Acronym / sponsor ID
- SCAST+ / 2023-03Obs-CHRMT
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, out-hospital care, medical regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- patient with emergency coronary angiography for ST+ ACS
- having made a call to the Emergency Center for the same reason
Key exclusion criteria (1 listed)
- non-real ST+ ACS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| symptoms of a myocardial infarctionAnalysis of the differences in symptoms of a myocardial infarction between a man and a woman | Other | – |
Primary outcome
Delay between the call to the emergency center and the first contact with a physician
Time frame: End of the call to the emergency center, less than 10 min
Delay (minutes:seconds)
6 secondary outcomes
Delay between the call to the emergency center and the first electrocardiogram
Time frame: At hospital discharge, an average of 2 hours
Dispatch of a medical ambulance (Y/N)
Time frame: 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
Time frame: At hospital discharge, an average of 2 hours
In-hospital mortality
Time frame: 30 days after the call to emergency center
Day 30 mortality
Time frame: 30 days after the call to emergency center
Left Ventricular Ejection Fraction
Time frame: At hospital discharge, less than 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laure ABENSUR VUILLAUME, MD, PhD principal investigator
CHR Metz Thionville Hopital de Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay between the call to the emergency center and the first contact with a physician (time frame: End of the call to the emergency center, less than 10 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.