Introduction of an 1-hour Algorithm for High-sensitivity Cardiac-specific Troponin T for Faster Assessment of NSTEMI in a Low-prevalence Population at Oslo Accident and Emergency Outpatient Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,750
- 试验地点
- 1
- 主要终点
- Number of patients transferred to the hospital (rule-in) according to the 1-hour algorithm
研究概览
简要总结
This study aims to evaluate if the 1-hour rule-in/rule-out algorithm for a high-sensitivity cardiac troponin T (hs-cTnT) is safe and effective for use in the primary care where the patients have a lower pretest probability of an acute myocardial infarction (MI). During this study troponins will be collected at 0-, 1- and 4/6-hours, where absolute changes in the values will decide whether the patient need hospitalization or not.
详细描述
Many patients seek Oslo Accident and Emergency Outpatient Clinic (OAEOC) with chest pain. The majority of these patients have symptoms suggestive of a benign non-cardiac chest pain. These patients do not need a directly transfer to the hospital, but can be admitted to the Observation Unit at the OAEOC for further pre-hospital testing, including serial troponins for a safe rule-out of acute MI. The main goal of this study is to improve the current routine at the Observation Unit at OAEOC by introducing the 1-hour algorithm for hs-cTnT for a faster rule-in/rule-out of acute MI.
All recruited patients will have serial troponins drawn at 0, 1- and 4/6 hours, with the main hypothesis that the absolute changes within 1 hour can be used as surrogates for the changes and conclusions drawn after 4/6 hours. The cut-off levels used within the 0/1-hour algorithm are assay specific as specified in the 2015 European Society of Cardiology Guidelines for the management of acute NSTEMI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 at the outpatient clinic with suspected non-cardiac chest pain/symptoms who need further testing for a safe rule-out of an acute MI
- •Written informed consent
排除标准
- •Acute STEMI (ST-elevation myocardial infarction) (directly to the hospital)
- •Strong suspicion of an acute NSTEMI/unstable angina (directly to the hospital)
- •Terminal kidney disease with a glomerular filtration rate (GFR) < 30
- •Unable to communicate in Norwegian, Swedish, Danish or English language
结局指标
主要结局
Number of patients transferred to the hospital (rule-in) according to the 1-hour algorithm
时间窗: 7-10 hours
The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.
Number of patients without significant changes (rule-out) according to the 1-hour algorithm
时间窗: 7-10 hours
The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.
次要结局
- Number of patients with NSTEMI admitted to the hospital from the Observation Unit at the OAEOC(1 week)
- Number of patients with significant change in the 3rd troponin (drawn after 4-6 hours) who were not identified by the 1-hour algorithm(10 hours)
- Significant changes between the first and second ECG?(6 hours)
- 90 days follow-up of all recruited patients(90 days)
研究者
Dan Atar
Professor of Cardiology and Head of Research
Oslo University Hospital