High-Sensitivity Cardiac Troponin On Presentation to Rule Out Myocardial Infarction
- Conditions
- Myocardial InfarctionAcute Coronary Syndrome
- Interventions
- Other: Implementation PhaseOther: Randomization PhaseOther: Validation Phase
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31492
- All consecutive patients with suspected acute coronary syndrome
- High-sensitivity cardiac troponin I measured as part of routine clinical care
- 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
- Arm && Interventions
Group Intervention Description Implementation Phase Implementation Phase 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. Randomization Phase Randomization Phase 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. Validation Phase Validation Phase 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.
- 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