Clinical trial NCT03005158: High-Sensitivity Cardiac Troponin On Presentation to Rule Out Myocardial Infarction
Official title: High-Sensitivity Cardiac Troponin On Presentation to Rule Out Myocardial Infarction (HiSTORIC): A Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Keywords: High-sensitivity cardiac troponin I
Myocardial infarction
Acute coronary syndrome
Cluster-randomized trial
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
name: NHS Greater Glasgow and Clyde
First posted: 2016-12-29
Enrollment: 31492
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Patients with suspected acute coronary syndrome account for a tenth of all presentations to the Emergency Department and up to 40 per cent of unplanned hospital admissions. The majority of patients do not have a heart attack (myocardial infarction), and may be safely discharged from the Emergency Department.

The investigators propose to evaluate whether the use of the HighSTEACS pathway in patients with suspected acute coronary syndrome reduces length of stay and allows more patients to be safely discharged from the Emergency Department. This pathways utilizes high-sensitivity cardiac troponin I testing and will rule out myocardial infarction if troponin concentrations are \<5 ng/L on presentation, with further testing indicated at 3 hours only in those presenting early or with troponin concentrations between 5 ng/L and the 99th centile.

In six secondary and tertiary centres across Scotland, the investigators will introduce the pathway as part of a stepped wedge cluster randomized controlled trial. Sequential hypothesis testing will evaluate the efficacy and safety of the pathway. The primary efficacy end-point will be length of stay from time of presentation until final hospital discharge and the primary safety end-point will be survival free from type 1 or 4b myocardial infarction or cardiac death from discharge to 30 days. The study population will consist of those patients with cardiac troponin concentrations within the normal reference range (\<99th centile) at presentation.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients with suspected acute coronary syndrome
* High-sensitivity cardiac troponin I measured as part of routine clinical care

Exclusion Criteria:

* Patients who are not resident in Scotland
* Patients with ST-segment elevation myocardial infarction
* Patients presenting to hospital in cardiac arrest
* Patients with presentation high-sensitivity cardiac troponin I concentrations greater than sex-specific 99th centile thresholds

Primary outcomes:
measure: Length of hospital stay (minutes)
timeFrame: Length of time from initial presentation to the Emergency Department until final discharge from hospital, an average of 24 hours.
measure: Type 1 or type 4b myocardial infarction or cardiac death after discharge and within 30 days of index admission
timeFrame: Hospital discharge to 30 days after initial presentation
Secondary outcomes:
measure: Proportion of patients discharged directly home from the Emergency Department
timeFrame: Presentation to discharge from hospital, an average of 24 hours.
measure: Type 1 or 4b Myocardial Infarction after hospital discharge (independently double adjudicated using all available clinical information)
timeFrame: Hospital discharge to 30 days and 1 year after initial presentation
measure: Cardiac death after hospital discharge (independently double adjudicated using all available clinical information)
timeFrame: Hospital discharge to 30 days and 1 year after initial presentation
measure: Cardiovascular death after hospital discharge (independently double adjudicated using all available clinical information)
timeFrame: Hospital discharge to 30 days and 1 year after initial presentation
measure: All-cause death after hospital discharge
timeFrame: Hospital discharge to 30 days and 1 year after initial presentation
measure: Unplanned coronary revascularisation after hospital discharge (from cardiac intervention databases and case note review)
timeFrame: Hospital discharge to 30 days and 1 year after initial presentation
measure: Proportion of patients re-attending the Emergency Department
timeFrame: Hospital discharge to 30 days and 1 year after initial presentation
Other outcomes:
measure: Pre-specified sub-group analyses of the primary outcome
timeFrame: length of hospital stay defined as the length of time from initial presentation to the Emergency Department until final discharge from hospital; safety follow-up time frame of 30 days and 1 year after hospital discharge
measure: Cost-effectiveness analysis
timeFrame: 1 year
Locations:
Study officials:
affiliation: University of Edinburgh
name: Nicholas L Mills, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Ian Ford, PhD
role: STUDY_CHAIR
References:
citation: Shah AS, Anand A, Sandoval Y, Lee KK, Smith SW, Adamson PD, Chapman AR, Langdon T, Sandeman D, Vaswani A, Strachan FE, Ferry A, Stirzaker AG, Reid A, Gray AJ, Collinson PO, McAllister DA, Apple FS, Newby DE, Mills NL; High-STEACS investigators. High-sensitivity cardiac troponin I at presentation in patients with suspected acute coronary syndrome: a cohort study. Lancet. 2015 Dec 19;386(10012):2481-8. doi: 10.1016/S0140-6736(15)00391-8. Epub 2015 Oct 8.
citation: Shah ASV, Anand A, Chapman AR, Newby DE, Mills NL; High-STEACS Investigators. Measurement of cardiac troponin for exclusion of myocardial infarction - Authors' reply. Lancet. 2016 Jun 4;387(10035):2289-2291. doi: 10.1016/S0140-6736(16)30517-7. No abstract available.
citation: Anand A, Lee KK, Chapman AR, Ferry AV, Adamson PD, Strachan FE, Berry C, Findlay I, Cruikshank A, Reid A, Collinson PO, Apple FS, McAllister DA, Maguire D, Fox KAA, Newby DE, Tuck C, Harkess R, Keerie C, Weir CJ, Parker RA, Gray A, Shah ASV, Mills NL; HiSTORIC Investigatorsdagger. High-Sensitivity Cardiac Troponin on Presentation to Rule Out Myocardial Infarction: A Stepped-Wedge Cluster Randomized Controlled Trial. Circulation. 2021 Jun 8;143(23):2214-2224. doi: 10.1161/CIRCULATIONAHA.120.052380. Epub 2021 Mar 23.
citation: Ferry AV, Strachan FE, Stewart SD, Marshall L, Lee KK, Anand A, Shah ASV, Chapman AR, Mills NL, Cunningham-Burley S. Exploring Patient Experience of Chest Pain Before and After Implementation of an Early Rule-Out Pathway for Myocardial Infarction: A Qualitative Study. Ann Emerg Med. 2020 Apr;75(4):502-513. doi: 10.1016/j.annemergmed.2019.11.012. Epub 2020 Jan 23.