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

Chest Pain Clinical Trial

— ICARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813499
• Other study ID #: AOI 2015-06
• Status: Completed
• First received: June 10, 2016
• Last updated: April 5, 2018
• Start date: November 2016
• Est. completion date: January 2018

Study information

• Verified date: April 2018
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1453
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient admitted to the emergency department or chest pain

• patient admitted in a non-scheduled manner

• non-traumatic chest pain

• no formal diagnosis after frontline examinations

Exclusion Criteria:

• patient with an ECG showing a coronary syndrome ST +

• patient for which a 6-weeks follow-up would be impossible

• patient refusing to participate

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain

Intervention

Other:
• CARE Rule
Evaluation of the clinical suspicion of myocardial infarction, calculation of CARE rule and troponin assay performed by the practitioner.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
France	University Hospital Angers	Angers
France	Hospital of Cholet	Cholet
France	SCHOTTE Thibault	Le Mans
France	Hospital of Saint-Malo	Saint Malo
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The failure rate of the diagnostic strategy will be evaluated by the rate of MACE recorded in the course of the phone call follow-up at 45 days of patient's inclusion in the group of patients with negative CARE rule.	This rate is a composite criterion including myocardial infarction, percutaneaous coronary intervention, coronary artery bypass grafting or sudden death for which a cardiac cause cannot be excluded. The procedure will be considered acceptable if the rate of false negatives among patients with negative CARE rule is less than 1% with an upper limit of the 95% confidence interval lower than 3%.	Day 45
Secondary	The failure rate of the HEART score only considering only one dosage of troponin at admission assessed by the proportion of MACE at 45 days in the HEART group =3		Day 45
Secondary	Number of bioassay which could be saved, measured by the difference between the number of bioassays actually made least the number bioassays requested by the strategy		Day 45
Secondary	Difference between average times of consultation according to the need for a bioassay based on CARE rule		Day 45