High-Sensitivity Cardiac Troponin On Presentation to Rule Out Myocardial Infarction (HiSTORIC): A Stepped Wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31,492
- 主要终点
- Type 1 or type 4b myocardial infarction or cardiac death after discharge and within 30 days of index admission
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients with suspected acute coronary syndrome
- •High-sensitivity cardiac troponin I measured as part of routine clinical care
排除标准
- •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
结局指标
主要结局
Type 1 or type 4b myocardial infarction or cardiac death after discharge and within 30 days of index admission
时间窗: Hospital discharge to 30 days after initial presentation
Length of hospital stay (minutes)
时间窗: 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
次要结局
- 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)
- 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)
- 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.)
- 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)