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定义参考人群以确定当代敏感型心肌肌钙蛋白 I 检测的第 99 个百分位数。

Defining a reference population to determine the 99th percentile of a contemporary sensitive cardiac troponin I assay.

机构信息

Department of Medicine II, University Medical Center, Johannes Gutenberg University, Mainz, Germany.

出版信息

Int J Cardiol. 2013 Aug 20;167(4):1423-9. doi: 10.1016/j.ijcard.2012.04.063. Epub 2012 May 4.

Abstract

BACKGROUND

Diagnosis of acute myocardial infarction (AMI) according to the universal definition is based on ischemic symptoms, imaging findings and elevated myocardial necrosis markers, preferably cardiac troponin I/T with diagnostic threshold representing the 99th percentile of a reference population. It is not clearly defined if this should be an unselected population-based or a healthy cohort with respect to cardiac diseases. Aim of the current study was to describe the distribution of troponin I using a sensitive assay and to evaluate the impact of cardiac diseases and cardiovascular risk factors in apparently healthy individuals.

METHODS

Troponin I was determined using a contemporary sensitive assay (TnI Ultra, Siemens) with 10% coefficient of variation (0.03 ng/mL) below the published 99th percentile (0.04 ng/mL) in 5000 participants (49.2% female) of the Gutenberg Health Study, a community-based, prospective, observational single-center cohort study. The calculated 99 th percentile cut-offs were tested in 1818 patients with suspected AMI.

RESULTS

Troponin I concentration representing the 99th percentile of the overall study population was 0.04 ng/mL. Excluding individuals with prevalent cardiovascular disease lowers the 99th percentile to 0.034 ng/mL. Exclusion of individuals with traditional risk factors or elevated natriuretic peptide leads to further reduction with 0.029/0.028 ng/mL. These lower cut-offs detect more patients at risk in individuals with suspected AMI. Correlations of troponin I with age, gender and traditional risk factors were observed.

CONCLUSIONS

Troponin I concentrations in apparently healthy individuals are dependent on prevalent cardiovascular diseases, traditional risk factors, gender and age. Application of corresponding cut-offs in diagnosis of AMI alters the group of patients potentially at risk.

摘要

背景

根据通用定义诊断急性心肌梗死(AMI)基于缺血症状、影像学发现和升高的心肌坏死标志物,最好是心脏肌钙蛋白 I/T,诊断阈值代表参考人群的第 99 百分位。目前尚不清楚这是应该针对所有人群还是针对无心脏疾病的健康队列。本研究的目的是使用敏感的检测方法描述肌钙蛋白 I 的分布,并评估心脏疾病和心血管危险因素对貌似健康个体的影响。

方法

使用一种灵敏的检测方法(Siemens 公司的 TnI Ultra)检测 5000 名(49.2%为女性)哥廷根健康研究参与者的肌钙蛋白 I,该研究是一项基于社区的前瞻性观察性单中心队列研究,其检测的 10%变异系数(CV)为 0.03ng/mL,低于公布的第 99 百分位(0.04ng/mL)。在 1818 名疑似 AMI 的患者中测试计算出的第 99 百分位截断值。

结果

代表整个研究人群第 99 百分位的肌钙蛋白 I 浓度为 0.04ng/mL。排除有心血管疾病的个体可将第 99 百分位降低至 0.034ng/mL。排除有传统危险因素或升高的利钠肽的个体可导致进一步降低至 0.029/0.028ng/mL。这些更低的截断值可在疑似 AMI 的个体中检测到更多的高危患者。观察到肌钙蛋白 I 与年龄、性别和传统危险因素之间的相关性。

结论

貌似健康个体的肌钙蛋白 I 浓度取决于已有的心血管疾病、传统危险因素、性别和年龄。在 AMI 的诊断中应用相应的截断值会改变潜在高危患者的群体。

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