Acute Coronary SyndromesECG-PHNMNCT07144059
Impact of Non-medicalized ECG Practices Initiated by SAMU in Dispatch Strategies
An observational study of Acute Coronary Syndromes, run by Centre Hospitalier Sud Francilien.
Trial summary
The performance of an ECG by non-medicalized prehospital teams (firefighters, first responders, paramedic ambulances) is developing across the territory to cope with the increasing demand (SAMU calls) for a service that cannot meet it (limited Mobile Emergency and Resuscitation Unit - SMUR - teams). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- ECG by the SMUR after medical interrogation by the SAMU and ECG performed by a non-medical vector
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: All patients regulated by the SAMU 91 in primary intervention in the Essonne department with ST+ ACS and admitted to the ICU or coronary angiography department
Who may be able to join
- Adult patient
- Patient regulated by the SAMU 91 between 09/2023 and 12/2024
- Patient referred for coronary angiography for ST+ ACS
- Patient registered in the E-Must register (Registry for the Evaluation in Emergency Medicine of Therapeutic Strategies for Myocardial Infarction of less than 24 hours treated by the SAMU/SMUR of Île-de-France)
Who cannot join
- Secondary transport
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Participants Are Not Assigned to Interventions Based on a Protocol
The performance of an ECG by non-medicalized prehospital teams (firefighters, first responders, paramedic ambulances) is developing across the territory to cope with the increasing demand (SAMU calls) for a service that cannot meet it (limited Mobile Emergency and Resuscitation Unit - SMUR - teams).
Early diagnosis of acute coronary syndrome is key to appropriate management. A delay in care can quickly lead to complications ranging from rhythm disorders to cardiac arrest. Furthermore, as with reperfusion in strokes, the earlier reperfusion treatment is initiated, the greater the beneficial effect in ST-segment elevation myocardial infarction (STEMI).
Read more
Moreover, the main elements for diagnosing STEMI in the prehospital setting remain the ECG, along with the anamnesis (medical history) and clinical examination (typical pain).
This is an observational, retrospective and single-center study (SAMU 91) carried out between September 1, 2023 and December 31, 2024. The inclusion criteria for our study were adult patients who had been regulated by SAMU 91 during a primary intervention and who had ST+ ACS registered in the eMUST registry. The main objective was to study the difference in the admission times of patients admitted to the emergency intensive care unit of cardiology or coronary angiography and presenting with ST+ ACS on the ECG performed by a primary SMUR team versus a non-medical team referred by the SAMU. The secondary objectives were to study the descriptive variables between the two groups (SMUR and non-medicalized vector), the typicity of pain, the mortality rate and the morbidity rate between the two groups.
Read the detailed description
The list of patients with ST+ ACS in department 91 during the year 2023 and 2024 were extracted from the E-Must registry (Registry for the Evaluation in Emergency Medicine of Therapeutic Strategies for Myocardial Infarction of less than 24 hours treated by the SAMU/SMUR of Île-de-France) and the missing information was retrieved via the SAMUScript medical regulation software (call schedules, address of the place of intervention,...)
- Conditions
- Acute Coronary Syndromes
- Being tested
- ECG by the SMUR after medical interrogation by the SAMU, ECG performed by a non-medical vector
- Keywords
- Acute coronary syndrome, infarct, STEMI, Electrocardiogram (ECG), Coronary angiography, SAMU, SMUR, Non-medical vectors
- Medical subject headings
- Acute Coronary Syndrome, Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG by the SMUR after medical interrogation by the SAMUOther
Patients who had the qualifying ECG by the SMUR after medical interrogation by the SAMU
ECG performed by a non-medical vectorOther
Patients who have called the emergency services with either an ECG performed by a non-medical vector (SP or ambulance), or a decision to reinforce SMUR during the first aid assessment
| Study group | Role | What they receive |
|---|---|---|
| EMS Vector | Patients who had the qualifying ECG by the SMUR after medical interrogation by the SAMU Receives: Other: ECG by the SMUR after medical interrogation by the SAMU | |
| ECG Vector: SP/Ambulances | Patients who have called the emergency services with either an ECG performed by a non-medical vector (SP or ambulance), or a decision to reinforce SMUR during the first aid assessment Receives: Other: ECG performed by a non-medical vector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Coronary Angiography or Cardiology Intensive Care Admission
Time between the time of the call for help and the arrival in the coronary angiography department or cardiology intensive care unit
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick HU, MD, Study director, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144059
- Sponsor's protocol ID
- 2025/0017
- Acronym
- ECG-PHNM
- Status last verified
- Dec 2025
- First submitted
- 20 Aug 2025
- Last updated
- 16 Dec 2025
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participants Are Not Assigned to Interventions Based on a Protocol
- ClinicalTrials.gov ID
- NCT07144059
- Acronym / sponsor ID
- ECG-PHNM / 2025/0017
- Conditions
- Acute Coronary Syndromes
- Keywords
- Acute coronary syndrome, infarct, STEMI, Electrocardiogram (ECG), Coronary angiography, SAMU, SMUR, Non-medical vectors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Aug 2025 (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 performance of an ECG by non-medicalized prehospital teams (firefighters, first responders, paramedic ambulances) is developing across the territory to cope with the increasing demand (SAMU calls) for a service that cannot meet it (limited Mobile Emergency and Resuscitation Unit - SMUR - teams).
Early diagnosis of acute coronary syndrome is key to appropriate management. A delay in care can quickly lead to complications ranging from rhythm disorders to cardiac arrest. Furthermore, as with reperfusion in strokes, the earlier reperfusion treatment is initiated, the greater the beneficial effect in ST-segment elevation myocardial infarction (STEMI).
Moreover, the main elements for diagnosing STEMI in the prehospital setting remain the ECG, along with the anamnesis (medical history) and clinical examination (typical pain).
This is an observational, retrospective and single-center study (SAMU 91) carried out between September 1, 2023 and December 31, 2024. The inclusion criteria for our study were adult patients who had been regulated by SAMU 91 during a primary intervention and who had ST+ ACS registered in the eMUST registry. The main objective was to study the difference in the admission times of patients admitted to the emergency intensive care unit of cardiology or coronary angiography and presenting with ST+ ACS on the ECG performed by a primary SMUR team versus a non-medical team referred by the SAMU. The secondary objectives were to study the descriptive variables between the two groups (SMUR and non-medicalized vector), the typicity of pain, the mortality rate and the morbidity rate between the two groups.
Detailed description
The list of patients with ST+ ACS in department 91 during the year 2023 and 2024 were extracted from the E-Must registry (Registry for the Evaluation in Emergency Medicine of Therapeutic Strategies for Myocardial Infarction of less than 24 hours treated by the SAMU/SMUR of Île-de-France) and the missing information was retrieved via the SAMUScript medical regulation software (call schedules, address of the place of intervention,...)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMS Vector | – | Other: ECG by the SMUR after medical interrogation by the SAMUPatients who had the qualifying ECG by the SMUR after medical interrogation by the SAMU |
| ECG Vector: SP/Ambulances | – | Other: ECG performed by a non-medical vectorPatients who have called the emergency services with either an ECG performed by a non-medical vector (SP or ambulance), or a decision to reinforce SMUR during the first aid assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients regulated by the SAMU 91 in primary intervention in the Essonne department with ST+ ACS and admitted to the ICU or coronary angiography department
Key inclusion criteria (4 listed)
- Adult patient
- Patient regulated by the SAMU 91 between 09/2023 and 12/2024
- Patient referred for coronary angiography for ST+ ACS
- Patient registered in the E-Must register (Registry for the Evaluation in Emergency Medicine of Therapeutic Strategies for Myocardial Infarction of less than 24 hours treated by the SAMU/SMUR of Île-de-France)
Key exclusion criteria (1 listed)
- Secondary transport
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 |
|---|---|---|
| ECG by the SMUR after medical interrogation by the SAMUPatients who had the qualifying ECG by the SMUR after medical interrogation by the SAMU | Other | EMS Vector |
| ECG performed by a non-medical vectorPatients who have called the emergency services with either an ECG performed by a non-medical vector (SP or ambulance), or a decision to reinforce SMUR during the first aid assessment | Other | ECG Vector: SP/Ambulances |
Primary outcome
Time to Coronary Angiography or Cardiology Intensive Care Admission
Time frame: day 0
Time between the time of the call for help and the arrival in the coronary angiography department or cardiology intensive care unit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- 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.
Patrick HU, MD study director
Centre Hospitalier Sud Francilien
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes, run by Centre Hospitalier Sud Francilien.
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 4 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: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurenne PARIS, MD (01 69 13 95 79 ext. +33, laurenne.paris@chsf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Coronary Angiography or Cardiology Intensive Care Admission (time frame: day 0). 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 16 Dec 2025.