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Abstract
Objective To evaluate the accuracy of a 2-h serial multiple biomarker (SMB) protocol for exclusion of myocardial infarction (MI) in the Emergency Department.
Methods A prospective, multicentre, observational study enrolled patients undergoing evaluation for possible MI. Blood samples at presentation and 2 h later were analysed for myoglobin, creatinine kinase-MB, troponin-I and B-natriuretic peptide. Thrombolysis in Myocardial Infarction (TIMI) score and National Heart Foundation of Australia/Cardiac Society of Australia and New Zealand (NHF/CSANZ) guideline for acute coronary syndrome were used to determine clinical risk. Primary outcome was MI diagnosed at index presentation. Secondary outcome was composite of all-cause mortality, MI and previously unplanned coronary revascularisation within 30 days.
Results 1758 patients were recruited. 168 (11%) of 1501 with data sufficient for analysis had MI, and 223 (14%) of 1620 had a secondary outcome. SMB sensitivity and specificity were 0.90 (95% CI 0.84 to 0.94) and 0.41 (95% CI 0.39 to 0.44) for MI. For 30-day outcome, SMB sensitivity and specificity were 0.84 (95% CI 0.78 to 0.88) and 0.41 (95% CI 0.39 to 0.44), compared with standard 8–12 h troponin sensitivity and specificity of 0.79 (95% CI 0.73 to 0.84) and 0.96 (95% CI 0.95 to 0.97). Combined with risk scores, SMB had sensitivity and specificity for MI of 0.99 (0.96 to 1.00) and 0.11 (95% CI 0.09 to 0.12) for TIMI score 0, compared with 0.98 (95% CI 0.94 to 0.99) and 0.31 (95% CI 0.29 to 0.34) for NHF/CSANZ low/intermediate risk groups.
Conclusions SMB alone is not sufficiently sensitive to exclude MI. Combined with risk scoring, SMB appears to identify patients at lower risk. This requires prospective validation.
- Chest pain
- acute coronary syndrome
- myocardial infarction
- biological markers
- early diagnosis
- cardiac care
- care systems
- diagnosis
- clinical assessment
- chest – non-trauma
- acute myocardial infarct
- research
- clinical
- emergency care systems
- efficiency
- data management
- emergency departments
- clinical care
- epidemiology
- thrombolysis
- analgesia pain control
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- Chest pain
- acute coronary syndrome
- myocardial infarction
- biological markers
- early diagnosis
- cardiac care
- care systems
- diagnosis
- clinical assessment
- chest – non-trauma
- acute myocardial infarct
- research
- clinical
- emergency care systems
- efficiency
- data management
- emergency departments
- clinical care
- epidemiology
- thrombolysis
- analgesia pain control
Footnotes
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Funding The study was funded entirely by a grant from the Western Australian Department of Health Innovation Fund. Alere Australia, Inc provided loan of analytical devices for the biomarker tests used in the study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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Competing interests SPJM and YN have spoken at meetings sponsored by Alere Australia Inc, although no payment was received or expenses claimed. SPJM has received materials from Alere to conduct independent research projects. None of the authors have any financial links with Alere or in any of its competitors. All authors are employed by the Health Department of Western Australia and/or the University of Western Australia.
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Ethics approval Approval provided by South Metropolitan Area Health Service Human Research Ethics Committee.
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Provenance and peer review Not commissioned; externally peer reviewed.
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