Ignite Creation Date:
2024-05-06 @ 8:45 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02813499
Status:
COMPLETED
Last Update Posted:
2018-04-06
First Post:
2016-06-10
Brief Title:
Interest of CARE Rule to Exclude the Hypothesis of an Acute Coronary Syndrome Without Bioassay - ICARE
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
Intérêt de la règle CARE Pour Exclure lhypothèse dun Syndrome Coronarien Aigu Sans Dosage Biologique - ICARE
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICARE
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
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
Detailed Description:
CARE rule was evaluated in a prospective study of routine care on 641 patients among which 98 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 0-19 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None