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Diagnostic accuracy of copeptin sensitivity and specificity in patients with suspected non-ST-elevation myocardial infarction with troponin I below the 99th centile at presentation.

ABSTRACT: To determine whether copeptin-us can rule out diagnosis of non-ST-segment elevation myocardial infarction (NSTEMI) without prolonged monitoring and serial blood sampling in patients with high-sensitive cardiac troponin I (hs-cTnI) below the 99th centile at presentation to the emergency department (ED) [corrected].Prospective, non-randomised, individual blinded diagnostic accuracy study.Two EDs of a rural region of France.Patients with chest pain suspected of NSTEMI with onset within the last 12 h were considered for enrollment.Serial clinical, electrographical and biochemical investigations were performed at admission and after 2, 4, 6 and 12 h. Hs-cTnI was measured using an assay with Dimension VISTA, Siemens [corrected]. Copeptin was measured by the BRAHMS copeptin-us assay on the KRYPTOR Compact Plus system. The follow-up period was 90 days.Copeptin, troponin, myoglobin and creatine kinase values. Clinical and paraclinical events. The final diagnosis was adjudicated blinded to copeptin result.During 12 months, 102 patients were analysed. Final diagnosis was NSTEMI for 7.8% (n=8), unstable angina for 3.9% (n=4), cardiac but non-coronary artery disease for 8.8% (n=9), non-cardiac chest pain for 52% (n=53) and unknown for 27.5% (n=28). There was no statistical difference for copeptin values between patients with NSTEMI and others (respectively 5.5 pmol/L IQR (3.1-7.9) and 6.5 pmol/L IQR (3.9-12.1), p=0.49). Only one patient with NSTEMI had a copeptin value above the cut-off of 95th centile at admission.In this study, copeptin does not add a diagnostic value at admission to ED for patients with suspected acute coronary syndrome without ST-segment elevation and with hs-cTnI below the 99th centile [corrected].Clinicaltrials.gov identifier: NCT01334645.

SUBMITTER: Duchenne J

PROVIDER: S-EPMC3975746 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Diagnostic accuracy of copeptin sensitivity and specificity in patients with suspected non-ST-elevation myocardial infarction with troponin I below the 99th centile at presentation.

Duchenne Jonathan J Mestres Stéphanie S Dublanchet Nicolas N Combaret Nicolas N Marceau Geoffroy G Caumon Laurent L Dutoit Laurent L Ughetto Sylvie S Motreff Pascal P Sapin Vincent V Schmidt Jeannot J

BMJ open 20140324 3

<h4>Objective</h4>To determine whether copeptin-us can rule out diagnosis of non-ST-segment elevation myocardial infarction (NSTEMI) without prolonged monitoring and serial blood sampling in patients with high-sensitive cardiac troponin I (hs-cTnI) below the 99th centile at presentation to the emergency department (ED) [corrected].<h4>Design</h4>Prospective, non-randomised, individual blinded diagnostic accuracy study.<h4>Setting</h4>Two EDs of a rural region of France.<h4>Participants</h4>Patie ...[more]

PMID: 24662448

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Project description:ObjectiveTo determine the distribution, and specifically the true 99th centile, of high sensitivity cardiac troponin I (hs-cTnI) for a whole hospital population by applying the hs-cTnI assay currently used routinely at a large teaching hospital.DesignProspective, observational cohort study.SettingUniversity Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom, between 29 June 2017 and 24 August 2017.Participants20 000 consecutive inpatients and outpatients undergoing blood tests for any clinical reason. Hs-cTnI concentrations were measured in all study participants and nested for analysis except when the supervising doctor had requested hs-cTnI for clinical reasons.Main outcome measuresDistribution of hs-cTnI concentrations of all study participants and specifically the 99th centile.ResultsThe 99th centile of hs-cTnI for the whole population was 296 ng/L compared with the manufacturer's quoted level of 40 ng/L (currently used clinically as the upper limit of normal; ULN). Hs-cTnI concentrations were greater than 40 ng/L in one in 20 (5.4%, n=1080) of the total population. After excluding participants diagnosed as having acute myocardial infarction (n=122) and those in whom hs-cTnI was requested for clinical reasons (n=1707), the 99th centile was 189 ng/L for the remainder (n=18 171). The 99th centile was 563 ng/L for inpatients (n=4759) and 65 ng/L for outpatients (n=9280). Patients from the emergency department (n=3706) had a 99th centile of 215 ng/L, with 6.07% (n=225) greater than the recommended ULN. 39.02% (n=48) of all patients from the critical care units (n=123) and 14.16% (n=67) of all medical inpatients had an hs-cTnI concentration greater than the recommended ULN.ConclusionsOf 20 000 consecutive patients undergoing a blood test for any clinical reason at our hospital, one in 20 had an hs-cTnI greater than the recommended ULN. These data highlight the need for clinical staff to interpret hs-cTnI concentrations carefully, particularly when applying the recommended ULN to diagnose acute myocardial infarction, in order to avoid misdiagnosis in the absence of an appropriate clinical presentation.Trial registrationClinicaltrials.gov NCT03047785.

Project description:BACKGROUND:Symptoms indicating acute coronary syndrome are commonly seen in emergency rooms, but only 10% of patients are actually diagnosed with acute myocardial infarction (AMI). The Guidelines for the diagnosis of patients with suspected AMI include either multiple testing of cardiac troponin (cTN) or a single combined test of cTN and copeptin, which facilitates earlier diagnosis or exclusion of AMI. The aim of the present analysis was to investigate the impact of combined copeptin/cTN testing on health care resource consumption and related costs both during and after initial hospital treatment. METHODS AND RESULTS:The analysis was based on the BIC-8 trial and financial data of participating study sites. A cost analysis was carried out primarily from the hospital perspective and secondarily from the perspective of German statutory health insurers. The underlying assumptions of the investigation were tested for robustness in additional sensitivity analyses. In total, the data of 713 patients (n = 359 combined copeptin/cTN testing, n = 354 serial cTN testing) were evaluated. From a hospital perspective, the combined copeptin/cTN testing showed a reduced number of medical procedures and a lower frequency of inpatient admissions. The average staff time was significantly reduced by a mean of 49 minutes (95% confidence interval (CI) 46 to 53) per patient, accompanied by a significant mean reduction of 131 minutes (95%CI 104 to 158) in the time patients stayed in the emergency room. The initial hospital treatment was less cost-intensive. Over the entire study period, no significant cost differences were observed between the groups for health insurance. CONCLUSION:The combined copeptin/cTN testing has the potential to save costs and staff time in acute care and for the entire hospital stay. The primary explanations for these findings are early identification and ruling out patients without AMI along with the associated reduced need for acute medical treatment. TRIAL REGISTRATION:ClinicalTrials.gov NCT01498731.

Project description:INTRODUCTION:Although the new generation of cardiac troponin assays have revolutionised the diagnosis of myocardial infarction (MI), their application in triaging patients with suspected acute coronary syndrome requires further investigation. The objectives of the current systematic review are to evaluate the diagnostic accuracy of contemporary and high-sensitivity cardiac troponin assays used in serial testing, versus single-sample testing as a comparator, to identify patients with non-ST-segment-elevation MI in the emergency department. METHODS AND ANALYSIS:We will conduct systematic searches of MEDLINE, EMBASE, Science Citation Index, the Cochrane Database of Systematic Reviews and the CENTRAL database covering the period from 1 January 2006 to present, with no restrictions on language or publication status. Two review authors will independently screen studies for inclusion, extract data from eligible studies and assess their methodological quality using Quality Assessment of Diagnostic Accuracy Studies version 2. Studies will be included if they evaluate contemporary or high-sensitivity cardiac troponin assays used in serial testing, in patients presenting to the ED with suspicion of MI. Estimates of sensitivity and specificity from each study will be presented in forest plots and in the receiver-operating characteristics space. If appropriate, we will pool the results using Bayesian hierarchical models that allow correction for imperfect reference standard. We will obtain summary estimates of sensitivity and specificity of alternative testing protocols and compare their accuracy. We will also investigate the impact of prespecified sources of heterogeneity and methodological quality items. If pooling of results is considered inappropriate, we will present our findings in tables and diagrams and will describe them narratively. ETHICS AND DISSEMINATION:No formal ethical approval will be sought, but we will report on the ethical approval of the included studies. Dissemination of findings will be through publications in peer-reviewed journals, presentations at conferences and the websites of the universities. PROSPERO REGISTRATION NUMBER:CRD42018106379.

Dataset Information

Diagnostic accuracy of copeptin sensitivity and specificity in patients with suspected non-ST-elevation myocardial infarction with troponin I below the 99th centile at presentation.

Publications

Diagnostic accuracy of copeptin sensitivity and specificity in patients with suspected non-ST-elevation myocardial infarction with troponin I below the 99th centile at presentation.

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