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

Sponsor
University Hospital, Angers (Other)
Overall Status
Recruiting
CT.gov ID
NCT04157790
Collaborator
(none)
2,080
10
2
18.9
208
11

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CARE score
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2080 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Efficacy of the CARE Rule Associated With the HEART Score in Patients With Emergency Chest Pain
Actual Study Start Date :
Jan 10, 2022
Anticipated Primary Completion Date :
Jul 9, 2023
Anticipated Study Completion Date :
Aug 9, 2023

Arms and Interventions

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)

Other: CARE score
CARE score calculation

Outcome Measures

Primary Outcome Measures

  1. Rate of major cardiac events [30 days]

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

Secondary Outcome Measures

  1. Rate of major cardiac events for the intention to treat study population [30 days]

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

  3. Time spent in the emergency department in the intention to treat population [2 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cliniques Universitaires Saint-Luc Bruxelles Belgium
2 CHU de Liège Liège Belgium
3 CHU Angers Angers France
4 Centre Hospitalier de Cholet Cholet France
5 CH Le Mans Le Mans France
6 Centre Hospitalier Universitaire de Rennes Rennes France
7 CH de Saint-Brieuc Saint-Brieuc France
8 CH de Saint-Malo Saint-Malo France
9 CHU Toulouse Toulouse France
10 CHU de Tours Tours France

Sponsors and Collaborators

  • University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT04157790
Other Study ID Numbers:
  • 49RC19_0071
First Posted:
Nov 8, 2019
Last Update Posted:
Mar 15, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2022