- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04157790
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
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thomas MOUMNEH, MD
- Phone Number: +33 0241356650
- Email: thomas.moumneh@chu-angers.fr
Study Contact Backup
- Name: Sandra MERZEAU
- Phone Number: +33 0241355970
- Email: samerzeau@chu-angers.fr
Study Locations
-
-
-
Bruxelles, Belgium
- Cliniques Universitaires Saint-Luc
-
Liège, Belgium
- CHU de Liège
-
-
-
-
-
Angers, France
- Chu Angers
-
Cholet, France
- Centre Hospitalier de Cholet
-
La Roche-sur-Yon, France, 85925
- CHD Vendee
-
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
Accepts Healthy Volunteers
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
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)
|
CARE score calculation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of major cardiac events for the intention to treat study population
Time Frame: 30 days
|
30 days
|
Number of troponin assays in the intention to treat population
Time Frame: 2 days
|
2 days
|
Time spent in the emergency department in the intention to treat population
Time Frame: 2 days
|
2 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 49RC19_0071
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chest Pain
-
Clinical Locomotion ScienceOdense University Hospital; University of Southern Denmark; The County of Funen... and other collaboratorsCompletedUndiagnosed Chest Pain | Musculoskeletal Chest Pain | Non-cardiac Chest PainDenmark
-
Academisch Medisch Centrum - Universiteit van Amsterdam...TerminatedFunctional Chest PainNetherlands
-
Atatürk UniversityCompletedPain, Acute | Pain, ChestTurkey
-
Queen's UniversityCompletedChest Pain Atypical SyndromeCanada
-
Universiti Sains MalaysiaCompletedNon Cardiac Chest PainMalaysia
-
Milton S. Hershey Medical CenterCompletedNoncardiac Chest Pain (NCCP)United States
-
Cairo UniversityActive, not recruitingNonspecific Cardiac Chest PainEgypt
-
Fayoum University HospitalCompleted
-
University of Texas Southwestern Medical CenterCompletedAcute Chest PainUnited States
-
Massachusetts General HospitalBracco Diagnostics, IncCompletedChest Pain SyndromeUnited States
Clinical Trials on CARE score
-
Catharina Ziekenhuis EindhovenRecruitingAcute Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromeNetherlands
-
UMC UtrechtZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedChest PainNetherlands
-
Hospices Civils de LyonCompleted
-
University Hospital, Clermont-FerrandAZUREA Network (www.azurea.org); ANARLF Network; Direction Générale de l'Offre...RecruitingAcute Brain Injury | Mechanical Ventilation | Altered Level of Consciousness | Mechanical Ventilator Weaning | Airway ControlFrance
-
University of Michigan Rogel Cancer CenterNational Institutes of Health (NIH); Myrexis Inc.; Veracyte, Inc.; MDx HealthRecruiting
-
QualiCCareNovo Nordisk A/S; Sanofi; Swiss Society of Endocrinology and Diabetology; Roche... and other collaboratorsCompletedDiabetes Mellitus, Type 2 | Primary CareSwitzerland
-
Johns Hopkins UniversityNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHypertension | Diabetes Mellitus | Chronic Disease | Congestive Heart FailureUnited States
-
Centre Oscar LambretNational Cancer Institute, France; Ligue contre le cancer, France; Région Nord-Pas...CompletedGastric Cancer | Esophageal Cancer | Bile Duct Cancer | Pancreas Cancer | Gastroesophageal CancerFrance
-
Uppsala UniversityThe Swedish Research Council; Swedish Heart Lung Foundation; Roche Diagnostics; Swedish Foundation for Strategic ResearchActive, not recruitingAtrial FibrillationSweden
-
University of VirginiaNot yet recruitingColonic Polyp | Colon CancerUnited States