Rapid Acute Coronary Syndrome Exclusion Using the Beckman Coulter Access High-sensitivity I Troponin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32,609
- 试验地点
- 2
- 主要终点
- Safe ED discharge
研究概览
简要总结
As part of the planned implementation of a new clinical pathway using hs-cTnI, the investigators will measure patient outcomes and clinical processes in a real-world scenario throughout an integrated health system across 9 emergency departments (ED).
详细描述
This is a pragmatic, implementation study testing the implications of a real-world execution of a rapid evaluation pathway for suspected ACS using the Beckman hs-cTnI assay. As the new protocol is executed across 9 EDs within an integrated health system, the investigators will study its effects on patient and system-level metrics. A modified stepped wedge design will be utilized that allows comparison of the RACE-IT pathway with standard of care management
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years old presenting to the ED for whom a treating clinician suspects ACS and orders a baseline ECG and cardiac troponin.
排除标准
- •ST-segment Myocardial Infarction (STEMI) leading to immediate reperfusion therapy
- •Any ED-drawn hs-cTnI value > 99th percentile (18 ng/L)
- •Clear traumatic cause for symptoms (e.g., direct chest wall trauma, motor vehicle accident)
- •A transfer from another facility
- •Primary residence outside the state of Michigan
- •Previous inclusion in the study
- •Enrolled in hospice
结局指标
主要结局
Safe ED discharge
时间窗: 30 days after initial presentation
Proportion of patients with safe discharges home from the ED, defined as being without death or acute myocardial infarction within 30-days
次要结局
- Number of participants with revascularization or rehospitalization for cardiovascular disease(30-days)
- Number of participants with death or acute myocardial infarction(30-day and through 1 year)
- Length of hospital stay(From date and time of start of emergency department encounter until date and time of end of ED or hospital encounter (whichever is latest), assessed up to 7 days.)
- Composite number of cardiology resources utilized(30-days)
- Hospital payments received(30-days)
研究者
Joseph Miller, MD
Principal Investigator
Henry Ford Health System