Sample and Method Comparison With Minicare® Point-of-care Device for Cardiac Troponin I Assay at the Emergency Department.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Method and sample comparison
研究概览
简要总结
This study is a prospective, observational, cohort study aiming to compare point-of-care high-sensitive troponin I testing from different sample types with central laboratory (CL) HS cTnI plasma samples.
A registry of all included patients and their troponin results (POC, CL and HS cTnT) will be made to compare these testing methods.
详细描述
Point-of-care (POC) troponin testing, defined as laboratory testing near a patient location with rapid availability of results, has attracted much interest in the emergency department setting (ED) and seems feasible. These devices might enable earlier decisions, reduce stay at the ED and improve patient flow. While an elevated troponin in patients with suspected acute coronary syndrome (ACS) confirms diagnosis and initiates adequate treatment, ruling out ACS aids in proper patient dismissal. A next step could be ruling out myocardial infarction by the general practitioner (GP) or fast responder using an on-site POC troponin test. However, drawing venous blood might not be easily available to every GP, especially not during peak hours. The Minicare cTnI is a bedside system which requires capillary blood, venous whole blood or plasma. The results of the troponin will be given within 10 minutes. It is a very sensitive troponin test, the most clinically sensitive available POC for c-Troponin. Currently Minicare prepares for a high sensitive troponin analysis targeting a reliable result within an hour after onset of chest pain. The objective of this study is to determine if high sensitive troponin testing by Minicare (POC HS cTnI) has the same analytical performance as standard high sensitivity troponin I testing in our central hospital laboratory ( CL HS cTnI ARCHITECT immunoassay analyzer, Abbott).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Method and sample comparison
时间窗: 30 days
The primary objective is to compare the analytical performance (method and sample comparison) of Minicare® high sensitive troponin I testing (POC, different sample types) and conventional venipuncture troponin I test in our central hospital laboratory (CL) with the Abbott Architect. This comparison will comprise: * Minicare® POC (different sample types) vs conventional HS cTnI CL test (Method comparison) * Minicare® capillary vs. Minicare® venipuncture and vs. Minicare® plasma (Sample comparison) The analyses linked to the primary objectives are: * The agreement between POC (three sample types) and CL testing by using the Bland-Altman method. * The agreement between different POC sample types by using the Bland-Altman method. The primary objective will be achieved by taking capillary and (an extra) venous blood samples (one per timepoint) from every patient presenting at the cardiac ED with chest pain suspected for ACS.
次要结局
- Linear regression and Pearson's correlation.(30 days)
- Fals-positive and fals-negatives.(30 days)
- Major adverse cardiac event (MACE)(30 days)
- Final patients diagnoses.(30 days)
- Safety analysis of POC troponin.(30 days)
- Overview baseline characteristics.(30 days)
研究者
Braim Rahel
Principal investigator/Cardiologist
VieCuri Medical Centre
