NCT04157790

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2023

Completed
Last Updated

October 23, 2023

Status Verified

July 1, 2023

Enrollment Period

1.3 years

First QC Date

November 5, 2019

Last Update Submit

October 20, 2023

Conditions

Chest Pain

Outcome Measures

Primary Outcomes (1)

  • Rate of major cardiac events

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

    30 days

Secondary Outcomes (3)

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

    30 days

  • Number of troponin assays in the intention to treat population

    2 days

  • Time spent in the emergency department in the intention to treat population

    2 days

Study Arms (2)

Neutral

NO INTERVENTION

Suggested to follow European Society of Cardiology guidelines for NSTEMI

CARE score

ACTIVE COMPARATOR

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)

Other: CARE score

Interventions

CARE scoreOTHER

CARE score calculation

CARE score

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • days follow-up not possible
  • ST-segment Elevation Myocardial Infarction (STEMI) on admittance ECG
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

CHU de Liège

Liège, Belgium

Location

CHU Angers

Angers, France

Location

Centre Hospitalier de Cholet

Cholet, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

CH Le Mans

Le Mans, France

Location

Centre Hospitalier Universitaire de Rennes

Rennes, France

Location

CH de Saint-Brieuc

Saint-Brieuc, France

Location

CH de Saint-Malo

St-Malo, France

Location

CHU Toulouse

Toulouse, France

Location

CHU de Tours

Tours, France

Location

Related Publications (1)

  • Moumneh T, Penaloza A, Charpentier S, Douillet D, Prunier F, Riou J, Roy PM. Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trial. BMJ Open. 2022 Dec 6;12(12):e066953. doi: 10.1136/bmjopen-2022-066953.

    PMID: 36600358DERIVED

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 8, 2019

Study Start

January 10, 2022

Primary Completion

May 5, 2023

Study Completion

September 19, 2023

Last Updated

October 23, 2023

Record last verified: 2023-07

Locations

FR(9)BE(2)