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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04157790
Acronym
eCARE
Enrollment
2153
Registered
2019-11-08
Start date
2022-01-10
Completion date
2023-09-19
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain

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.

Interventions

OTHERCARE score

CARE score calculation

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of major cardiac events30 daysMyocardial infarction, percutaneous or surgical coronary reperfusion, certain or potential cardiac death, or surviving cardiac arrest

Secondary

MeasureTime frame
Number of troponin assays in the intention to treat population2 days
Rate of major cardiac events for the intention to treat study population30 days
Time spent in the emergency department in the intention to treat population2 days

Countries

Belgium, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026