Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,256
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
Registry of an interventional Study-proved Strategy (BIC-8) using Copeptin and Troponin for the Early Rule-Out of Acute Myocardial Infarction (AMI) in Patients with Suspected Acute Coronary Syndrome (ACS) and a low-to intermediate risk profile.
详细描述
Registry of an interventional Study-proved Strategy (BIC-8) using Copeptin and Troponin for the Early Rule-Out of Acute Myocardial Infarction (AMI) in Patients with Suspected Acute Coronary Syndrome (ACS) and a low-to intermediate risk profile.
Primary objective:
To monitor the safety of the early rule-out strategy using combined testing of copeptin and troponin at admission of patients with signs and symptoms suggestive of ACS and a low- to intermediate risk profile, who are discharged or moved to another hospital after testing copeptin and troponin negative (defined as copeptin below 10 pmol/l and cardiac troponin below 99th percentile URL).
Secondary objectives:
- To monitor routine application of the early rule-out strategy, patient characteristics, risk profile of all patients tested for copeptin and troponin at admission, irrespective of their biomarker test result
- To monitor diagnoses, clinical course and outcome of all patients tested for copeptin and troponin at admission
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Admission to the Emergency Department or CPU with signs and symptoms consistent with acute coronary syndrome
- •Low-to intermediate risk profile (GRACE-score below 140 and a low- to intermediate likelihood of ACS as judged by the treating physician)
- •Patients eligible for the early rule-out strategy using combined copeptin and troponin testing at admission, irrespective of biomarker test results and disposition decision
- •full-aged patient
排除标准
- 未提供
结局指标
主要结局
All-cause mortality
时间窗: 30 days
One-month all-cause mortality in patients in whom acute myocardial infarction is ruled-out using the early rule-out strategy and who are therefore discharged from the ED
次要结局
未报告次要终点
研究者
Martin Moeckel
Univ. Prof. Dr.
Charite University, Berlin, Germany