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

Chest Pain Clinical Trial

— eCARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04157790
• Other study ID #: 49RC19_0071
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: September 19, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2153
• Est. completion date: September 19, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chest Pain
• Emergencies

Intervention

Other:
• CARE score
CARE score calculation

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	CHU de Liège	Liège
France	CHU Angers	Angers
France	Centre Hospitalier de Cholet	Cholet
France	CHD Vendée	La Roche-sur-Yon
France	CH Le Mans	Le Mans
France	Centre Hospitalier Universitaire de Rennes	Rennes
France	CH de Saint-Brieuc	Saint-Brieuc
France	CH de Saint-Malo	Saint-Malo
France	CHU Toulouse	Toulouse
France	CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of major cardiac events	Myocardial infarction, percutaneous or surgical coronary reperfusion, certain or potential cardiac death, or surviving cardiac arrest	30 days
Secondary	Rate of major cardiac events for the intention to treat study population		30 days
Secondary	Number of troponin assays in the intention to treat population		2 days
Secondary	Time spent in the emergency department in the intention to treat population		2 days