Chest PainReg-HARNCT06859021
Validation of the HAR Score for Prioritization of Patients Calling the Emergency Medical Service for Chest Pain by Emergency Call Dispatcher
An observational study of Chest Pain, run by Centre Hospitalier le Mans at 3 sites in France.
Trial summary
The lifetime prevalence of chest pain in the general population is 20-40%. The etiologies to be evoked from the outset of management are those of cardiovascular origin, such as acute coronary syndrome (ACS) and pulmonary embolism. ACS is responsible for almost 20% of deaths. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- What is being tested?
- follow up call
- How many people
- 796 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Dec 2025to 1 Jul 2027
- 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: Patients calling center 15 for chest pain
Who may be able to join
- Patient of legal age (≥ 18 years)
- Calling Center 15 from 49, 72 or 37
- Expressing non-traumatic chest pain, even if this is not the main reason for seeking help.
Who cannot join
- Treatment in departments other than 49, 72 and 37
- Poor understanding of the French language
- Non-affiliated or non-beneficiary of a social security scheme
- Person deprived of liberty by judicial or administrative decision
- Person under forced psychiatric care
- Person subject to a legal protection measure
Show all 9Show fewer
- Person unable to express his/her non-opposition.
- Follow-up at Day 30 impossible for any reason
- Person having expressed his/her opposition to the collection of his/her data.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Angers
Angers, 49000
Damien DUVAL, MD, +332 41 35 36 37, damien.duval@chu-angers.fr
Damien DUVAL, MD
- Recruiting
Centre Hospitalier Le Mans
Le Mans, 72000
Christelle JADEAU, MD, +332 44 71 07 81, cjadeau@ch-lemans.fr
Cyrielle HOUALARD, MD
- Recruiting
CHRU de Tours
Tours, 37000
Mickael SOLETCHNIK, MD, +33247474747, m.soletchnik@chu-tours.fr
Mickael SOLETCHNIK, MD
About this study
Official title: Validation of the HAR Score for Prioritization of Patients Calling the Emergency Medical Service for Chest Pain by Emergency Call Dispatcher : Reg-HAR Study
The lifetime prevalence of chest pain in the general population is 20-40%. The etiologies to be evoked from the outset of management are those of cardiovascular origin, such as acute coronary syndrome (ACS) and pulmonary embolism. ACS is responsible for almost 20% of deaths. Delay in treatment is a major prognostic factor, given the importance of coronary reperfusion.
In France, one of the first contacts with the healthcare system is the medical regulation assistant (MRA) at the Centre 15. His or her role is to prioritize the call according to the identification of immediate signs of seriousness, and if necessary, to decide autonomously to send a rescue team before medical regulation. Depending on the reason for the call and any signs of seriousness, it prioritizes the call according to the expected response time. In line with current recommendations, all calls for chest pain should be answered by an emergency medical dispatcher (EMR) within 5 minutes. However, 60-90% of chest pain calls are not of cardiovascular origin. Their prioritization could therefore be re-qualified for longer response times.
Read more
Given the frequency of this type of call, a more efficient MRA referral strategy is needed. To achieve this, decision-support tools would be essential.
The performance of the HAR (History, Age and Risk Factors) score has been recently explored, derived from the HEART score, in a previous single-center prospective study in 2019. It stratifies the risk of a major cardiovascular event (MCE) into low (0 or 1 point), intermediate (2 or 3 points) or high (4, 5 or 6 points).
Investigator's hypothesis is that the HAR score could be entrusted to MRA, to enable them to optimize the prioritization of patients calling with non-traumatic chest pain, by qualifying low-risk chest pain calls on the one hand, which could be prioritized in P2 SNP, and high-risk calls on the other, making it possible to anticipate the dispatch of an emergency service.
- Conditions
- Chest Pain
- Being tested
- follow up call
- Keywords
- Chestpain, HAR score, Emergency call
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow up callOther
A follow-up call is made to the patient 30 days (+ 5 days) after inclusion to check for the occurrence of an Major Cardio Vascular Event.
| Study group | Role | What they receive |
|---|---|---|
| call for chest pain | patients who call for chest pain Receives: Other: follow up call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of major cardiovascular events
Number of major cardiovascular events is measured by presence of Death from cardiological causes, Type 1 or 2 myocardial infarction, Percutaneous coronary intervention, Surgical coronary bypass surgery
Measured: 30 days
Secondary outcomes (4)
Performance of the HAR Score: Sensitivity, Specificity, and Comparison Between EMR and MRA
Sensitivity, specificity, likelihood ratios of the HAR score at different decision thresholds and the area under the ROC curve, as well as reclassification rates between the evaluation of the HAR score by the EMR (Emergency Medical Dispatcher) and the MRA (Medical Regulation Assistant)
Measured: From Day 0 to Day 30
Comparaison between rescue resources decided and predicted by the HAR score
The proportion of rescue resources (SMUR - VSAV...) that would have been decided according to the HAR score (≥ 4 points) compared to the proportion of rescue resources actually decided upon
Measured: From Day 0 to Day 30
Time delta between the end of the MRA's score suggesting the dispatch of equipment (HAR score ≥ 4 points) and the actual decision to dispatch equipment in the current situation.
Measured: From Day 0 to Day 30
Area under the ROC curve and Delong-Delong test
Measured: From Day 0 to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Dec 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 796 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859021
- Sponsor's protocol ID
- CHM-2024-S01-08
- Acronym
- Reg-HAR
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the HAR Score for Prioritization of Patients Calling the Emergency Medical Service for Chest Pain by Emergency Call Dispatcher : Reg-HAR Study
- ClinicalTrials.gov ID
- NCT06859021
- Acronym / sponsor ID
- Reg-HAR / CHM-2024-S01-08
- Conditions
- Chest Pain
- Keywords
- Chestpain, HAR score, Emergency call
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 796 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 5 Mar 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 lifetime prevalence of chest pain in the general population is 20-40%. The etiologies to be evoked from the outset of management are those of cardiovascular origin, such as acute coronary syndrome (ACS) and pulmonary embolism. ACS is responsible for almost 20% of deaths. Delay in treatment is a major prognostic factor, given the importance of coronary reperfusion.
In France, one of the first contacts with the healthcare system is the medical regulation assistant (MRA) at the Centre 15. His or her role is to prioritize the call according to the identification of immediate signs of seriousness, and if necessary, to decide autonomously to send a rescue team before medical regulation. Depending on the reason for the call and any signs of seriousness, it prioritizes the call according to the expected response time. In line with current recommendations, all calls for chest pain should be answered by an emergency medical dispatcher (EMR) within 5 minutes. However, 60-90% of chest pain calls are not of cardiovascular origin. Their prioritization could therefore be re-qualified for longer response times.
Given the frequency of this type of call, a more efficient MRA referral strategy is needed. To achieve this, decision-support tools would be essential.
The performance of the HAR (History, Age and Risk Factors) score has been recently explored, derived from the HEART score, in a previous single-center prospective study in 2019. It stratifies the risk of a major cardiovascular event (MCE) into low (0 or 1 point), intermediate (2 or 3 points) or high (4, 5 or 6 points).
Investigator's hypothesis is that the HAR score could be entrusted to MRA, to enable them to optimize the prioritization of patients calling with non-traumatic chest pain, by qualifying low-risk chest pain calls on the one hand, which could be prioritized in P2 SNP, and high-risk calls on the other, making it possible to anticipate the dispatch of an emergency service.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| call for chest pain | – | Other: follow up callpatients who call for chest pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients calling center 15 for chest pain
Key inclusion criteria (3 listed)
- Patient of legal age (≥ 18 years)
- Calling Center 15 from 49, 72 or 37
- Expressing non-traumatic chest pain, even if this is not the main reason for seeking help.
Key exclusion criteria (9 listed)
- Treatment in departments other than 49, 72 and 37
- Poor understanding of the French language
- Non-affiliated or non-beneficiary of a social security scheme
- Person deprived of liberty by judicial or administrative decision
- Person under forced psychiatric care
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 |
|---|---|---|
| follow up callA follow-up call is made to the patient 30 days (+ 5 days) after inclusion to check for the occurrence of an Major Cardio Vascular Event. | Other | call for chest pain |
Primary outcome
Number of major cardiovascular events
Time frame: 30 days
Number of major cardiovascular events is measured by presence of Death from cardiological causes, Type 1 or 2 myocardial infarction, Percutaneous coronary intervention, Surgical coronary bypass surgery
4 secondary outcomes
Performance of the HAR Score: Sensitivity, Specificity, and Comparison Between EMR and MRA
Time frame: From Day 0 to Day 30
Comparaison between rescue resources decided and predicted by the HAR score
Time frame: From Day 0 to Day 30
Time delta between the end of the MRA's score suggesting the dispatch of equipment (HAR score ≥ 4 points) and the actual decision to dispatch equipment in the current situation.
Time frame: From Day 0 to Day 30
Area under the ROC curve and Delong-Delong test
Time frame: From Day 0 to Day 30
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 8 Sep 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain, run by Centre Hospitalier le Mans at 3 sites 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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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 Christelle JADEAU (+33244710781, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of major cardiovascular events (time frame: 30 days). 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 8 Sep 2026.