Efficacy of the CARE Rule Associated With the HEART Score in Patients With Emergency Chest Pain (eCARE)
Primary Purpose
Chest Pain
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CARE score
Sponsored by
About this trial
This is an interventional diagnostic trial for Chest Pain
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.
Sites / Locations
- Cliniques Universitaires Saint-Luc
- CHU de Liège
- CHU Angers
- Centre Hospitalier de Cholet
- CHD Vendée
- CH Le Mans
- Centre Hospitalier Universitaire de Rennes
- CH de Saint-Brieuc
- CH de Saint-Malo
- CHU Toulouse
- CHU de Tours
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Neutral
CARE score
Arm Description
Suggested to follow European Society of Cardiology guidelines for NSTEMI
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)
Outcomes
Primary Outcome Measures
Rate of major cardiac events
Myocardial infarction, percutaneous or surgical coronary reperfusion, certain or potential cardiac death, or surviving cardiac arrest
Secondary Outcome Measures
Rate of major cardiac events for the intention to treat study population
Number of troponin assays in the intention to treat population
Time spent in the emergency department in the intention to treat population
Full Information
NCT ID
NCT04157790
First Posted
November 5, 2019
Last Updated
October 20, 2023
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT04157790
Brief Title
Efficacy of the CARE Rule Associated With the HEART Score in Patients With Emergency Chest Pain
Acronym
eCARE
Official Title
Efficacy of the CARE Rule Associated With the HEART Score in Patients With Emergency Chest Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
May 5, 2023 (Actual)
Study Completion Date
September 19, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
2153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neutral
Arm Type
No Intervention
Arm Description
Suggested to follow European Society of Cardiology guidelines for NSTEMI
Arm Title
CARE score
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
CARE score
Intervention Description
CARE score calculation
Primary Outcome Measure Information:
Title
Rate of major cardiac events
Description
Myocardial infarction, percutaneous or surgical coronary reperfusion, certain or potential cardiac death, or surviving cardiac arrest
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Rate of major cardiac events for the intention to treat study population
Time Frame
30 days
Title
Number of troponin assays in the intention to treat population
Time Frame
2 days
Title
Time spent in the emergency department in the intention to treat population
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
Country
Belgium
Facility Name
CHU de Liège
City
Liège
Country
Belgium
Facility Name
CHU Angers
City
Angers
Country
France
Facility Name
Centre Hospitalier de Cholet
City
Cholet
Country
France
Facility Name
CHD Vendée
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
CH Le Mans
City
Le Mans
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes
City
Rennes
Country
France
Facility Name
CH de Saint-Brieuc
City
Saint-Brieuc
Country
France
Facility Name
CH de Saint-Malo
City
Saint-Malo
Country
France
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Facility Name
CHU de Tours
City
Tours
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy of the CARE Rule Associated With the HEART Score in Patients With Emergency Chest Pain
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