Chest Pain Clinical Trial
Official title:
Intérêt de la règle CARE Pour Exclure l'hypothèse d'un Syndrome Coronarien Aigu Sans Dosage Biologique - ICARE
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.
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.
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