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

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.

Study Overview

• Status: Completed
• Conditions: Chest Pain
• Intervention / Treatment: Other: CARE score

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.

• Study Type: Interventional
• Enrollment (Actual): 2153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium
    • Cliniques universitaires Saint-Luc
  • Liège, Belgium
    • CHU de Liege
• France
  • Angers, France
    • Chu Angers
  • Cholet, France
    • Centre Hospitalier de Cholet
  • La Roche-sur-Yon, France, 85925
    • CHD Vendée
  • Le Mans, France
    • CH Le mans
  • Rennes, France
    • Centre Hospitalier Universitaire de Rennes
  • Saint-Brieuc, France
    • CH de Saint-Brieuc
  • Saint-Malo, France
    • CH de Saint-Malo
  • Toulouse, France
    • Chu Toulouse
  • Tours, France
    • CHU de Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Neutral; Suggested to follow European Society of Cardiology guidelines for NSTEMI
Active Comparator: CARE score; 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; CARE score calculation

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): September 19, 2023

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Chest Pain
• Other Study ID Numbers: 49RC19_0071

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No