High-Sensitivity Cardiac Troponin On Presentation to Rule Out Myocardial Infarction (HiSTORIC)

University of Edinburgh

Status: Completed

Conditions: Acute Coronary Syndrome; Myocardial Infarction

Treatments: Other: Validation Phase; Other: Randomization Phase; Other: Implementation Phase

Study type: Interventional

Funder types: Other

Identifiers

NCT03005158

PG/15/51/31596

Details and patient eligibility

About

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.

Enrollment: 31,492 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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31,492 participants in 3 patient groups

Validation Phase

Other group

Description:

All six hospital sites currently use the ARCHITECT STAT high- sensitive troponin I assay in the assessment of patients with suspected acute coronary syndrome and use sex-specific thresholds upper reference limits (99th centile) to rule out myocardial infarction. This validation phase of up to 10 months will provide baseline information for each site on patients with suspected acute coronary syndrome in whom myocardial infarction is ruled out.

Treatment:

Other: Validation Phase

Randomization Phase

Other group

Description:

Participating centres will be randomized to implement the HighSTEACS pathway (intervention). The order of implementation will be randomized, with paired participating centres implementing in steps over a 6 month period.

Treatment:

Other: Randomization Phase

Implementation Phase

Active Comparator group

Description:

A final phase of up to 10 months after implementation of the HighSTEACS pathway will be matched by calendar month in each site to that of the validation phase, allowing each participating centre to act as its own control and to adjust for seasonal differences in the incidence of myocardial infarction and mortality.

Treatment:

Other: Implementation Phase