- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06859021
Validation of the HAR Score for Prioritization of Patients Calling the Emergency Medical Service for Chest Pain by Emergency Call Dispatcher (Reg-HAR)
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.
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 Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christelle JADEAU
- Phone Number: +33244710781
- Email: cjadeau@ch-lemans.fr
Study Contact Backup
- Name: Cyrielle HOUALARD, MD
- Phone Number: +33243434343
- Email: choualard@ch-lemans.fr
Study Locations
-
-
-
Angers, France, 49000
- Recruiting
- Centre Hospitalier Universitaire D'Angers
-
Contact:
- Damien DUVAL, MD
- Phone Number: +332 41 35 36 37
- Email: damien.duval@chu-angers.fr
-
Principal Investigator:
- Damien DUVAL, MD
-
Le Mans, France, 72000
- Recruiting
- Centre Hospitalier Le Mans
-
Contact:
- Christelle JADEAU, MD
- Phone Number: +332 44 71 07 81
- Email: cjadeau@ch-lemans.fr
-
Principal Investigator:
- Cyrielle HOUALARD, MD
-
Tours, France, 37000
- Recruiting
- CHRU de Tours
-
Contact:
- Mickael SOLETCHNIK, MD
- Phone Number: +33247474747
- Email: m.soletchnik@chu-tours.fr
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Principal Investigator:
- Mickael SOLETCHNIK, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
call for chest pain
patients who call for chest pain
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance of the HAR Score: Sensitivity, Specificity, and Comparison Between EMR and MRA
Time Frame: From Day 0 to Day 30
|
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)
|
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
|
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
|
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
|
From Day 0 to Day 30
|
|
|
Area under the ROC curve and Delong-Delong test
Time Frame: From Day 0 to Day 30
|
From Day 0 to Day 30
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHM-2024-S01-08
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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