High-Sensitivity Cardiac Troponin On Presentation to Rule Out Myocardial Infarction (HiSTORIC): A stepped wedge cluster randomised trial
National guidelines now recommend the use of high-sensitivity cardiac troponin assays to rule out myocardial infarction earlier in patients with suspected acute coronary syndrome. However, the optimal strategy is unknown, and the safety of these approaches in routine clinical practice has not been determined. In secondary and tertiary care hospitals across Scotland, we propose a controlled trial of the implementation of a novel pathway with a high-sensitivity cardiac troponin to rule out myocardial infarction on presentation using an admission troponin threshold of 5 ng/L. The objective is to evaluate the safety and efficacy of this novel pathway across ~35,000 consecutive patients with suspected acute coronary syndrome. We anticipate that implementation of an early rule out pathway in routine clinical practice will be safe and associated with major healthcare savings, and that our findings will form the basis of future guidelines for acute coronary syndrome.
Chief Investigator: Professor Nicholas Mills
Number and location of participating sites (by region/ country): 6 sites across Lothian and Greater Glasgow & Clyde
Funder: British Heart Foundation (PG/15/51/31596) and Chief Scientists Office (Scotland)
Start and End date of grant: July 2015 – June 2018
Current status: Recruitment complete - in follow up
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Sponsor: University of Edinburgh, NHS Lothian Health Board ACCORD
Chief Investigator: Professor Nicholas Mills, Room SU225, Chancellor's Building, University of Edinburgh, Royal Infirmary, Little France, Edinburgh, EH16 4SB, UK
Clinical Research Manager: Fiona Strachan
Trial Manager: Chris Tuck
ECTU involvement: Trial management / Statistics / Database