Cardiac Biomarkers:Comparison Between Analytical Methods
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Evaluate current and new laboratory methods and assays
研究概览
简要总结
In the western world the prevalence of myocardial infarction is estimated at around 1-2% of the population; increases progressively with age, reaching a percentage of 10% after the 75 years.
It is therefore considered the first cause of hospitalization and mortality in Western countries, as well as expenditure for the health system.
It is therefore very important to have cardiac biomarkers that allow to confirm the diagnostic suspicion of coronary heart disease and/or heart failure, carry out prognostic evaluations and stratify patients as precisely as possible in relation to their actual risk.
Currently as biomarkers of heart failure, natriuretic peptides (BNP and NT-proBNP) are widely used in clinical practice but, considering the complexity of heart failure and its clinical and pathophysiological heterogeneity, it is reasonable to think that a single biomarker is not sufficient . For these reasons, there is increasing interest in the scientific community in the search for new biomarkers useful for early diagnosis, for correct prognostic stratification and for evaluating the response to therapy.
详细描述
The study aims to evaluate the analytical performance of different kits and molecular markers commercially available (or in pre-industrial development phase) for the assays of the cardiac biomarkers: cTnI , NT-proBNP and sST2.
500 samples (residual serum) from patients hospitalized and/or referred to the DEA Department, for which troponin and/or NT-proBNP tests have been requested routinely or urgently by clinicians, will be included in the study.
The analytical performance of the various kits and the intra- and interassay imprecision will be evaluated. Comparison of methods will be calculated by Passing-Bablok regression and graph by Bland-Altman.
Through the non-parametric Passing-Bablok model the obtained data will be compared with the various analytical methods, reporting them one in function of the other, together with the regression line.
From the regression equation, the proportional systematic error will be evaluated as angular coefficient of the straight line and the constant systematic error as an intercept of the equation
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Patients arriving in the emergency room with chest pain of presumable cardiac origin and uncertain etiological diagnosis
- •Routine request for cardiac Troponin and NT-ProBNP
排除标准
- •Age <18 years;
- •No requirement for cardiac Troponin and NT-ProBNP
结局指标
主要结局
Evaluate current and new laboratory methods and assays
时间窗: 24 months
The analytical performance of the assay will be evaluated according to the Clinical and Laboratory Standards Institute (CLSI) EP15-A3 guidelines with the aim to highlight the differences respect to the methods currently used in laboratory and optimize the diagnostic accuracy and precison of the available tests. Comparison between different methods with different analytical sensitivity for the same cardiac biomarker (eg Troponin ultra- Troponin Singulex- Troponin Hs).
Evaluate new cardiac biomarkers
时间窗: 24 months
Evaluate new cardiac biomarkers (eg sST2) to implement in the panel of available assays, in response to clinician requests, international guidelines and the emerging potential of new biochemical tests. Evaluate the medium-long term (1 year) predictive value of the new biomarker in the heart patients attending at the Emergency Department for non-STEMI Acute Chest Pain.
次要结局
- Create a multiparametric algorithm/score(36 months)
研究者
Baroni Silvia
Confirmed researcher - Adjunct Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS