Background Observational studies suggest that the Manchester Acute Coronary Syndromes (MACS) decision rule can effectively ‘rule out’ and ‘rule in’ acute coronary syndromes (ACS) following a single blood test. In a pilot randomised controlled trial, we aimed to determine whether a large trial is feasible.
Methods Patients presenting to two EDs with suspected cardiac chest pain were randomised to receive care guided by the MACS decision rule (intervention group) or standard care (controls). The primary efficacy outcome was a successful discharge from the ED, defined as a decision to discharge within 4 hours of arrival providing that the patient did not have a missed acute myocardial infarction (AMI) or develop a major adverse cardiac event (MACE: death, AMI or coronary revascularisation) within 30 days. Feasibility outcomes included recruitment and attrition rates.
Results In total, 138 patients were included between October 2013 and October 2014, of whom 131 (95%) were randomised (66 to intervention and 65 controls). Nine (7%) patients had prevalent AMI and six (5%) had incident MACE within 30 days. All 131 patients completed 30-day follow-up and were included in the final analysis with no missing data for the primary analyses. Compared with standard care, a significantly greater proportion of patients whose care was guided by the MACS rule were successfully discharged within 4 hours (26% vs 8%, adjusted OR 5.45, 95% CI 1.73 to 17.11, p=0.004). No patients in either group who were discharged within 4 hours had a diagnosis of AMI or incident MACE within 30 days (0.0%, 95% CI 0% to 20.0% in the intervention group).
Conclusions In this pilot trial, use of the MACS rule led to a significant increase in safe discharges from the ED but a larger, fully powered trial remains necessary. Our findings seem to support the feasibility of that trial.
Trial registration number ISRCTN 86818215.
Research Ethics Committee reference: 13/NW/0081.
UKCRN registration ID:14334.
- Acute myocardial infarction
- Acute Coronary Syndromes
- Sensitivity and Specificity
- Troponins, high sensitivity
- Emergency Medicine
- Clinical Decision Rules
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Contributors All authors have contributed to this work and meet the ICMJE criteria for authorship.
Funding This trial was funded by the National Institute for Health Research via a postdoctoral fellowship grant (reference PDF-2012-05-193) awarded to Richard Body.
The trial was sponsored by Central Manchester University Hospitals NHS Foundation Trust.
Except for the sponsors providing the required monitoring and governance checks, the sponsors and funders of this work played no role in the design and conduct of the study; the data collection; analysis; decision to publish; or preparation of the manuscript.
Disclaimer This article/paper/report presents independent research funded by NIHR. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests RB has previously undertaken research involving donation of reagents without charge by Roche, Abbott, Alere, Siemens and Randox. His institution has received remuneration for research funded and/or sponsored by Roche, Abbott Point of Care, FABPulous BV, Abbott Laboratories, Portola, Novartis, Shire and Boehringer Ingelheim. He has accepted the provision of economy class travel and accommodation to present findings unrelated to this work at two Roche-sponsored conferences and at a scientific session sponsored by Randox.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement For queries relating to the trial protocol and for additional data from this study, please contact the corresponding author, Richard Body.
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