Efficacy of the CARE Rule Associated With the HEART Score in Patients With Emergency Chest Pain

Study Overview
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Brief Summary
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Acute coronary syndrome (ACS) is a major public health problem and its diagnosis remains a challenge for the emergency physician. The European Society of Cardiology recommends a troponin dosage and renew it if necessary during any suspicion of ACS. However, the criteria leading to initiate a diagnostic procedure during chest pain are imprecise. The fear is, on the one hand, to miss a potentially vital diagnosis and, on the other hand, to expose a large number of patients to unnecessary examinations. The CARE rule (also known as HEAR score) seems to streamline this first step. It assigns a value of 0 to 2 using 4 items: Characteristic of pain, Age, Risk factors and Electrocardiogram (ECG). The search for an ACS is not justified if the sum of the points is <2 (negative rule) and, inversely, a troponin determination must be carried out if the sum is > 1 (positive rule). The aim of the study is to demonstrate the safety and interest of the CARE rule associated with the HEART score to streamline ACS's diagnostic approach to thoracic pain in emergencies departments.

Detailed Description
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Data collected in this study are not anticipated to be published in a data repository. However, data will be shared per requested need to researchers, upon presentation of a structured protocol, when approved by the competent ethic committee and approved by the steering committee.

Official Title
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Efficacy of the CARE Rule Associated With the HEART Score in Patients With Emergency Chest Pain

Conditions
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Chest Pain

Intervention / Treatment
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* Other: CARE score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admission to an Emergency Department participating in the study Non-traumatic chest pain Age greater than or equal to 18 years Patient's consent (oral for France, written for Belgium) Exclusion Criteria: 30 days follow-up not possible ST-segment Elevation Myocardial Infarction (STEMI) on admittance ECG Chest pain formally reported to a diagnosis other than an ACS before inclusion (e.g., pneumothorax, pleurisy, etc.) Troponin assay performed prior to inclusion (less than 24 hours old) Patient referred by another care structure (excluding primary medicine) Patient already included in study still in follow-up period Pregnant, breastfeeding or parturient patient, Patient deprived of liberty by judicial or administrative decision, Patient undergoing psychiatric care under duress, Patient subject to a legal protection measure, Patient unable to give free and informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Neutral<br>Suggested to follow European Society of Cardiology guidelines for NSTEMI | |
| Active Comparator: CARE score<br>calculation of the CARE score and prescription for troponins assays or not according to the result (score > 1: troponins assays ; score < 2: no troponins assays) | Other: CARE score<br>* CARE score calculation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major cardiac events | Myocardial infarction, percutaneous or surgical coronary reperfusion, certain or potential cardiac death, or surviving cardiac arrest | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major cardiac events for the intention to treat study population |  | 30 days | 
| Number of troponin assays in the intention to treat population |  | 2 days | 
| Time spent in the emergency department in the intention to treat population |  | 2 days |