We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02813499
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : April 6, 2018
Information provided by (Responsible Party):
University Hospital, Angers

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.

Condition or disease Intervention/treatment
Chest Pain Other: CARE Rule

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1453 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intérêt de la règle CARE Pour Exclure l'hypothèse d'un Syndrome Coronarien Aigu Sans Dosage Biologique - ICARE
Actual Study Start Date : November 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Group/Cohort Intervention/treatment
Evaluation of the clinical suspicion of myocardial infarction and calculation of CARE rule.
Other: CARE Rule
Evaluation of the clinical suspicion of myocardial infarction, calculation of CARE rule and troponin assay performed by the practitioner.

Primary Outcome Measures :
  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. [ Time Frame: Day 45 ]
    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%.

Secondary Outcome Measures :
  1. 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 [ Time Frame: Day 45 ]
  2. 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 [ Time Frame: Day 45 ]
  3. Difference between average times of consultation according to the need for a bioassay based on CARE rule [ Time Frame: Day 45 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with non-traumatic chest pain

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813499

Layout table for location information
Cliniques Universitaires Saint-Luc
Brussels, Belgium
University Hospital Angers
Angers, France, 49933
Hospital of Cholet
Cholet, France
SCHOTTE Thibault
Le Mans, France
Hospital of Saint-Malo
Saint Malo, France
University Hospital Toulouse
Toulouse, France
Sponsors and Collaborators
University Hospital, Angers
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02813499    
Other Study ID Numbers: AOI 2015-06
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Angers:
Acute Coronary Syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Coronary Syndrome
Chest Pain
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Neurologic Manifestations