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

NCT02813499 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1453

Last updated 2018-04-06

No results posted yet for this study

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

Interventions

OTHER

CARE Rule

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

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02813499 on ClinicalTrials.gov