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高敏心肌肌钙蛋白I与当代心肌肌钙蛋白I诊断急性心肌梗死的诊断性能比较

Diagnostic Performance of High Sensitivity Compared with Contemporary Cardiac Troponin I for the Diagnosis of Acute Myocardial Infarction.

作者信息

Sandoval Yader, Smith Stephen W, Thordsen Sarah E, Bruen Charles A, Carlson Michelle D, Dodd Kenneth W, Driver Brian E, Jacoby Katherine, Johnson Benjamin K, Love Sara A, Moore Johanna C, Sexter Anne, Schulz Karen, Scott Nathaniel L, Nicholson Jennifer, Apple Fred S

机构信息

Division of Cardiology, Hennepin County Medical Center and Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN.

Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN.

出版信息

Clin Chem. 2017 Oct;63(10):1594-1604. doi: 10.1373/clinchem.2017.272930. Epub 2017 Jul 12.

Abstract

BACKGROUND

We examined the diagnostic performance of high-sensitivity cardiac troponin I (hs-cTnI) vs contemporary cTnI with use of the 99th percentile alone and with a normal electrocardiogram (ECG) to rule out acute myocardial infarction (MI) and serial changes (deltas) to rule in MI.

METHODS

We included consecutive patients presenting to a US emergency department with serial cTnI onclinical indication. Diagnostic performance for acute MI, including MI subtypes, and 30-day outcomes were examined.

RESULTS

Among 1631 patients, MI was diagnosed in 12.9% using the contemporary cTnI assay and in 10.4% using the hs-cTnI assay. For ruling out MI, contemporary cTnI ≤99th percentile at 0, 3, and 6 h and a normal ECG had a negative predictive value (NPV) of 99.5% (95% CI, 98.6-100) and a sensitivity of 99.1% (95% CI, 97.4-100) for diagnostic and safety outcomes. Serial hs-cTnI measurements ≤99th percentile at 0 and 3 h and a normal ECG had an NPV and sensitivity of 100% (95% CI, 100-100) for diagnostic and safety outcomes. For ruling in MI, contemporary cTnI measurements had specificities of 84.4% (95% CI, 82.5-86.3) at presentation and 78.7% (95% CI, 75.4-82.0) with serial testing at 0, 3, and 6 h, improving to 89.2% (95% CI, 87.1-91.3) by using serial cTnI changes (delta, 0 and 6 h) >150%. hs-cTnI had specificities of 86.9% (95% CI, 85.1-88.6) at presentation and 85.7% (95% CI, 83.5-87.9) with serial testing at 0 and 3 h, improving to 89.3% (95% CI, 87.3-91.2) using a delta hs-cTnI (0 and 3 h) >5 ng/L.

CONCLUSIONS

hs-cTnI and contemporary cTnI assays are excellent in ruling out MI following recommendations predicated on serial testing and the 99th percentile with a normal ECG. For ruling in MI, deltas improve the specificity. ClinicalTrials.gov Identifier: NCT02060760.

摘要

背景

我们使用单独的第99百分位数以及结合正常心电图(ECG)来排除急性心肌梗死(MI),并利用连续变化值(差值)来诊断MI,以此研究高敏心肌肌钙蛋白I(hs-cTnI)与当代肌钙蛋白I(cTnI)的诊断性能。

方法

我们纳入了因临床指征而连续接受cTnI检测的美国急诊科患者。研究了急性MI(包括MI亚型)的诊断性能以及30天的预后情况。

结果

在1631例患者中,采用当代cTnI检测法诊断出MI的比例为12.9%,采用hs-cTnI检测法诊断出MI的比例为10.4%。对于排除MI,当代cTnI在0、3和6小时时≤第99百分位数且ECG正常,其诊断和安全性结局的阴性预测值(NPV)为99.5%(95%CI,98.6 - 100),敏感性为99.1%(95%CI,97.4 - 100)。hs-cTnI在0和3小时时连续测量值≤第99百分位数且ECG正常,其诊断和安全性结局的NPV和敏感性均为l00%(95%CI,100 - 100)。对于诊断MI,当代cTnI检测在就诊时的特异性为84.4%(95%CI,82.5 - 86.3),在0、3和6小时进行连续检测时的特异性为78.7%(95%CI,75.4 - 82.0),通过使用连续cTnI变化值(0和6小时的差值)>150%,特异性提高到89.2%(95%CI,87.1 - 91.3)。hs-cTnI在就诊时的特异性为86.9%(95%CI,85.1 - 88.6),在0和3小时进行连续检测时的特异性为85.7%(95%CI,83.5 - 87.9),通过使用hs-cTnI(0和3小时的差值)>5 ng/L,特异性提高到89.3%(95%CI,87.3 - 91.2)。

结论

hs-cTnI和当代cTnI检测在按照基于连续检测、第99百分位数以及正常ECG的建议来排除MI方面表现出色。对于诊断MI,差值可提高特异性。ClinicalTrials.gov标识符:NCT02060760。

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