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Completed

NCT Number: NCT04157790

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

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.

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Key information

Conditions

Chest Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint-Luc, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CARE score

Other

CARE score calculation

Primary outcomes

  1. Rate of major cardiac events

    Time frame: 30 days

    Myocardial infarction, percutaneous or surgical coronary reperfusion, certain or potential cardiac death, or surviving cardiac arrest

Secondary outcomes

  1. Rate of major cardiac events for the intention to treat study population

    Time frame: 30 days

  2. Number of troponin assays in the intention to treat population

    Time frame: 2 days

  3. Time spent in the emergency department in the intention to treat population

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: eCARE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2019
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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