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

Not Applicable

Completed

• Conditions: Myocardial Infarction; Acute Coronary Syndrome

• Registration Number: NCT03005158
• Lead Sponsor: University of Edinburgh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2016-12-29
• Primary Completion: 2017-01-02
• Study Completion: 2021-12-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31492

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Type 1 or type 4b myocardial infarction or cardiac death after discharge and within 30 days of index admission	Hospital discharge to 30 days after initial presentation
Length of hospital stay (minutes)	Length of time from initial presentation to the Emergency Department until final discharge from hospital, an average of 24 hours.	This time frame is unique to each patient

Secondary Outcome Measures

Name	Time	Method
Unplanned coronary revascularisation after hospital discharge (from cardiac intervention databases and case note review)	Hospital discharge to 30 days and 1 year after initial presentation	We will identify any patients who require unplanned percutaneous coronary intervention or coronary artery bypass grafting.
Type 1 or 4b Myocardial Infarction after hospital discharge (independently double adjudicated using all available clinical information)	Hospital discharge to 30 days and 1 year after initial presentation	An adjudicated diagnosis of type 1 and type 4b myocardial infarction will be made in line with the universal definition of myocardial infarction, using all available clinical information.
All-cause death after hospital discharge	Hospital discharge to 30 days and 1 year after initial presentation
Cardiac death after hospital discharge (independently double adjudicated using all available clinical information)	Hospital discharge to 30 days and 1 year after initial presentation
Proportion of patients discharged directly home from the Emergency Department	Presentation to discharge from hospital, an average of 24 hours.	Time frame of initial hospital episode is unique to each patient
Cardiovascular death after hospital discharge (independently double adjudicated using all available clinical information)	Hospital discharge to 30 days and 1 year after initial presentation
Proportion of patients re-attending the Emergency Department	Hospital discharge to 30 days and 1 year after initial presentation