Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,239
- 试验地点
- 1
- 主要终点
- Number of participants with the diagnosis NSTE-ACS
研究概览
简要总结
Patients with a non-ST-segment elevation acute coronary syndrome (NSTE-ACS) are currently transported and admitted to the nearest emergency department (ED) for risk stratification, diagnostic workup, and treatment. Recently, several prospective studies have been performed on the diagnostic performance of point-of-care (POC)-troponin and combined risk scores (CRS) for pre-hospital risk assessment and triage of NSTE-ACS patients. Also the first intervention trials on triage decisions based on POC troponin and CRS have been performed. Initial results are indicating that prehospital triage based on these diagnostic tools is feasible and safe, although sample sizes were relatively small and underpowered to detect differences in major adverse cardiac events (MACE). The objective of this individual patient data meta-analysis is to determine the diagnostic performance of POC troponin and combined risk scores for prehospital risk assessment and triage in suspected NSTE-ACS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients suspected for NSTE-ACS;
- •Prospective study
- •Original data
- •Presenting prehospital (EMS)
- •Prehospital risk assessment using at least POC-troponin, performed and analyzed by EMS.
- •Outcome data available on in-hospital ACS or MACE within 30 days.
排除标准
- •Enrolling only a specific subpopulation from the general ACS population
- •Studies with less than 100 patients
- •Studies enrolling only patients with STEMI.
- •Studies published before 1995 / the pre-troponin era
- •Studies performed by general practitioners.
研究组 & 干预措施
Usual care
Patients who receive usual care by EMS protocols
干预措施: Usual care (Other)
point-of-care troponin
Patients in who risk-stratification was performed by the use of a point-of-care troponin in the EMS setting
干预措施: point-of-care troponin (Device)
Combined risk scores
Patients in who risk-stratification was performed by the use of a combined risk score in the EMS setting
干预措施: Combined risk score (Device)
结局指标
主要结局
Number of participants with the diagnosis NSTE-ACS
时间窗: During index hospitalization, up to 1 day in the ED
Diagnosis of NSTE-ACS (NSTEMI or unstable AP) during index hospitalization (as assessed by the treating physician)
MACE
时间窗: Within 30 days
All cause death, myocardial infarction, revascularization
次要结局
- MACE(1 week)
- Total health care costs(At 30 days)
- All cause death(Within 30 days and 1 year follow-up)
- The number of participants undergoing invasive coronary angiography(During or after index hospitalisation, up to 30 days)
- The number of participants undergoing coronary revascularisation(During or after index hospitalisation, up to 30 days)
- Alternative diagnoses other than NSTE-ACS(during 30 day follow-up after inclusion)
- Safety endpoints concerning intracoronary angiography and/or PCI(during 30 day follow-up after intracoronary angiography and/or PCI)
- Health care utilization(Within 30 days after inclusion)
- Health care utilization(Up to 30 days after inclusion)
研究者
Pieter-Jan Vlaar
Principal Investigator
Catharina Ziekenhuis Eindhoven