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

NCT02813499 | Completed

• 1 other identifier: AOI 2015-06
• Study Type: observational
• Target: 1,453
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Chest Pain

Keywords

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• Difference between average times of consultation according to the need for a bioassay based on CARE rule

  Day 45

Study Arms (1)

CARE Rule

Evaluation of the clinical suspicion of myocardial infarction and calculation of CARE rule.

Other: CARE Rule

Interventions

CARE Rule OTHER

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

CARE Rule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with non-traumatic chest pain

You may qualify if:

• 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

You may not qualify if:

• patient with an ECG showing a coronary syndrome ST +
• patient for which a 6-weeks follow-up would be impossible
• patient refusing to participate

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (6)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

University Hospital Angers

Angers, 49933, France

Location

Hospital of Cholet

Cholet, France

Location

SCHOTTE Thibault

Le Mans, France

Location

Hospital of Saint-Malo

St-Malo, France

Location

University Hospital Toulouse

Toulouse, France

Location

Related Publications (1)

• Moumneh T, Penaloza A, Cismas A, Charpentier S, Schotte T, Pernet S, Malatest S, Prunier F, Warnant A, Mezdad TH, Gangloff C, Soulat L, Douillet D, Riou J, Roy PM. Evaluation of HEAR score to rule-out major adverse cardiac events without troponin test in patients presenting to the emergency department with chest pain. Eur J Emerg Med. 2021 Aug 1;28(4):292-298. doi: 10.1097/MEJ.0000000000000791.

  PMID: 34187993 DERIVED

MeSH Terms

Conditions

Chest Pain; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 27, 2016
• Study Start: November 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: April 6, 2018

Record last verified: 2018-04

Locations

FR (5); BE (1)