Clinical trial NCT04157790: Efficacy of the CARE Rule Associated With the HEART Score in Patients With Emergency Chest Pain
Official title: Efficacy of the CARE Rule Associated With the HEART Score in Patients With Emergency Chest Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-11-08
Enrollment: 2153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of major cardiac events
timeFrame: 30 days
Secondary outcomes:
measure: Rate of major cardiac events for the intention to treat study population
timeFrame: 30 days
measure: Number of troponin assays in the intention to treat population
timeFrame: 2 days
measure: Time spent in the emergency department in the intention to treat population
timeFrame: 2 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Liège
country: Belgium
facility: CHU de Liège
city: Angers
country: France
facility: CHU Angers
city: Cholet
country: France
facility: Centre Hospitalier de Cholet
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Le Mans
country: France
facility: CH Le Mans
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
city: Saint-Brieuc
country: France
facility: CH de Saint-Brieuc
city: Saint-Malo
country: France
facility: CH de Saint-Malo
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU de Tours
Study officials:
References: