Abstract / Description of output

In six hospitals across Scotland, we are undertaking a study to evaluate
the efficacy and safety of implementation of an early rule out
diagnostic pathway using a high-sensitivity cardiac troponin to rule
out myocardial infarction on presentation in approximately 35,000
consecutive patients with suspected acute coronary syndrome.
There will be three study phases each of six months duration: a validation
phase using only the standard care pathway; a randomization
phase within which the six sites are randomized to start the intervention
at one of three time points 8 weeks apart; and an implementation
phase calendar matched to the validation phase with all sites
using the new pathway. Patients with suspected myocardial infarction
will be recruited as they present and then followed-up for
30 days. Sequential hypothesis testing will evaluate two co-primary
endpoints in an a-priori defined hierarchical order: (1) the proportion
of patients discharged from the Emergency Department (efficacy
endpoint), and (2) the proportion with myocardial infarction or death
at 30 days (safety endpoint test for non-inferiority).
The trial is in progress and results are expected in 2018. To control
the overall Family-Wise Error Rate for the study we will use a serial
gatekeeping procedure.
The study design consists of a hybrid before-and-after and stepped
wedge trial design. The stepped wedge component enables us to
make cross-sectional comparisons as well as within-site comparisons;
the before-and-after component allows us to completely adjust for
seasonal effects and evaluate the intervention when it is fully embedded
into normal practice.
This abstract is being presented on behalf of the HiSTORIC trial group. The
HiSTORIC trial is funded by the British Heart Foundation (PG/15/51/31596).
RP and CW were supported in this work by NHS Lothian via the Edinburgh
Health Services Research Unit.
Original languageEnglish
Title of host publicationTrials
PublisherBioMed Central
Number of pages1
EditionSuppl 1
Publication statusPublished - 18 Jul 2016
EventInternational Conference on Stepped Wedge Trial Design - York, United Kingdom
Duration: 10 Mar 201610 Mar 2016


ConferenceInternational Conference on Stepped Wedge Trial Design
Country/TerritoryUnited Kingdom

Keywords / Materials (for Non-textual outputs)

  • Stepped Wedge Trial Design


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