Document Detail


Randomised Assessment of Treatment using Panel Assay of Cardiac markers--Contemporary Biomarker Evaluation (RATPAC CBE).
MedLine Citation:
PMID:  23597479     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: To test the diagnostic accuracy for detecting an acute myocardial infarction (AMI) using highly sensitive troponin assays and a range of new cardiac biomarkers of plaque destabilisation, myocardial ischaemia and necrosis; to test the prognostic accuracy for detecting adverse cardiac events using highly sensitive troponin assays and this range of new cardiac biomarkers; and to estimate the cost-effectiveness of using highly sensitive troponin assays or this range of new cardiac biomarkers instead of an admission and 10- to 12-hour troponin measurement.
DESIGN: Substudy of the point-of-care arm of the RATPAC (Randomised Assessment of Treatment using Panel Assay of Cardiac markers) trial.
SETTING: The emergency departments of six hospitals.
PARTICIPANTS: Prospective admissions with chest pain and a non-diagnostic electrocardiogram randomised to point-of-care assessment or conventional management.
INTERVENTIONS: Blood samples taken on admission and 90 minutes from admission for measurement of cardiac markers [cardiac troponin I (cTnI), myoglobin and creatine kinase MB isoenzyme (CK-MB)] by point-of-care testing. An additional blood sample was taken at admission and 90 minutes from admission for analysis of high-sensitivity cTnI (two methods) and cardiac troponin T (cTnT), myoglobin, heart-type fatty acid-binding protein (H-FABP), copeptin and B-type natriuretic peptide (NTproBNP).
MAIN OUTCOME MEASURES: 1. Diagnostic accuracy compared with the universal definition of myocardial infarction utilising laboratory measurements of cardiac troponin performed at the participating sites together with measurements performed in a core laboratory. 2. Ability of biomarker measurements to predict major adverse cardiac events (death, non-fatal AMI, emergency revascularisation or hospitalisation for myocardial ischaemia) at 3 months' follow-up. 3. Comparison of incremental cost per quality-adjusted life-year (QALY) of different biomarker measurement strategies for the diagnosis of myocardial infarction.
RESULTS: Samples were available from 850 out of 1132 patients enrolled in the study. Measurement of admission myoglobin [area under the curve (AUC) 0.76] and CK-MB (AUC 0.84) was diagnostically inferior and did not add to the diagnostic efficiency of cTnI (AUC 0.90-0.94) or cTnT (AUC 0.92) measurement on admission. Simultaneous measurement of H-FABP and cTnT or cTnI did improve admission diagnostic sensitivity to 0.78-0.92, but only to the same level as that achieved with troponin measured on admission and at 90 minutes from admission (0.78-0.95). Copeptin (AUC 0.62) and NTproBNP (AUC 0.85) measured on admission were not useful as diagnostic markers. As a prognostic marker, troponin measured on admission using a high-sensitivity assay (AUC 0.73-0.83) was equivalent to NTproBNP measurement (AUC 0.77) on admission, but superior to copeptin measurement (AUC 0.58). From modelling, 10-hour troponin measurement is likely to be cost-effective compared with rapid rule-out strategies only if a £30,000 per QALY threshold is used and patients can be discharged as soon as a negative result is available.
CONCLUSIONS: The measurement of high-sensitivity cardiac troponin is the best single marker in patients presenting with chest pain. Additional measurements of myoglobin or CK-MB are not clinically effective or cost-effective. The optimal timing for measurement of cardiac troponin remains to be defined. Copeptin measurement is not recommended. H-FABP requires further investigation before it can be recommended for simultaneous measurement with high-sensitivity troponin in patients with acute chest pain.
TRIAL REGISTRATION: ISRCTN37823923.
FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 15. See the HTA programme website for further project information.
Authors:
P O Collinson; D C Gaze; P Thokala; S Goodacre
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Health technology assessment (Winchester, England)     Volume:  17     ISSN:  2046-4924     ISO Abbreviation:  Health Technol Assess     Publication Date:  2013  
Date Detail:
Created Date:  2013-04-19     Completed Date:  2013-11-25     Revised Date:  2014-05-19    
Medline Journal Info:
Nlm Unique ID:  9706284     Medline TA:  Health Technol Assess     Country:  England    
Other Details:
Languages:  eng     Pagination:  v-vi, 1-122     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ISRCTN/ISRCTN37823923
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MeSH Terms
Descriptor/Qualifier:
Acute Disease
Biological Markers
Cost-Benefit Analysis
Creatine Kinase, MB Form
Emergency Service, Hospital*
Fatty Acid-Binding Proteins / blood
Glycopeptides / blood
Humans
Myocardial Infarction / blood*,  metabolism
Myocardial Ischemia / blood*,  metabolism
Myoglobin / blood
Natriuretic Peptide, Brain / blood
Peptide Fragments / blood
Point-of-Care Systems*
Prognosis
Prospective Studies
Sensitivity and Specificity
Troponin I / blood*,  diagnostic use*
Troponin T / blood,  diagnostic use
Grant Support
ID/Acronym/Agency:
09/22/16//Department of Health; HTA/09/22/16//Department of Health
Chemical
Reg. No./Substance:
0/Biological Markers; 0/FABP3 protein, human; 0/Fatty Acid-Binding Proteins; 0/Glycopeptides; 0/Myoglobin; 0/Peptide Fragments; 0/Troponin I; 0/Troponin T; 0/copeptins; 0/pro-brain natriuretic peptide (1-76); 114471-18-0/Natriuretic Peptide, Brain; EC 2.7.3.2/Creatine Kinase, MB Form

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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