NCT02813499

Interest of CARE Rule to Exclude the Hypothesis of an Acute Coronary Syndrome Without Bioassay - ICARE

Intérêt de la règle CARE Pour Exclure l'hypothèse d'un Syndrome Coronarien Aigu Sans Dosage Biologique - ICARE

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,453 (actual)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Acute coronary syndrome (ACS) is a major health problem and its diagnosis remains a challenge for the emergency physician. The management of a suspected ACS is well codified, based on troponin assays, renewed if necessary. Conversely, the criteria leading to initiate a diagnostic procedure in chest pain to the Emergency department are unclear. The fear is, firstly, to miss a potentially life treating diagnosis and, secondly, exposing many patients to unnecessary examinations. The advent of highly sensitive troponin assays also increases the risk of over-investigation by a larger number of elevations of the biomarker in non-coronary circumstances leading to a prolongation of hospitalization and, possibly, unnecessary treatments and invasive investigations. CARE rule could help to streamline this first step. It is established by assigning a value from 0 to 2 to the items: Characteristic of pain, Age, Risk factors and ECG. The search for an ACS is not justified if the sum of points is ≤1 (negative rule) and, conversely, a troponin should be performed if the sum is \> 1 (positive rule). Indeed, CARE rule corresponds to the first 4 items of the HEART score (the latter standing for troponin at admission) whose reliability has been demonstrated, a ≤3 income excluding ACS with a risk of false negatives \<2%. A negative CARE rule always corresponds to a HEART score ≤3. Our study aims to confirm the interest of CARE rule to streamline the search for an ACS in chest pain as an observational European multicenter prospective study.

Detailed description

CARE rule was evaluated in a prospective study of routine care on 641 patients among which 9.8% had a Major Adverse Cardiac Event (MACE). 200 patients (31%) had a negative rule and none showed MACE during the 45-day follow-up (0% \[0-1.9\]). Among these 200 patients, 119 had a standard troponin assay, a single dosage was increased. The main objective is to demonstrate the reliability of CARE rule to exclude ACS in chest pain, using an observational Franco-Belgian multicenter study in routine care. If the reliability of CARE rule is confirmed in Emergency departments, it could be evaluated to be used in other circumstances such as in pre-hospital or in private practice for the general practitioner or cardiologist. In summary, the ICARE study is intended to allow a rationalization of the management of patients with chest pain, limiting the use of unnecessary investigations while ensuring the safety of care.

Conditions

• Chest Pain

Interventions

Type	Name	Description
OTHER	CARE Rule	Evaluation of the clinical suspicion of myocardial infarction, calculation of CARE rule and troponin assay performed by the practitioner.

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2016-06-27
• Last updated: 2018-04-06

Locations

6 sites across 2 countries: Belgium, France