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通过连续肌钙蛋白检测发现急性冠状动脉综合征以快速评估心脏缺血症状(FAST-TRAC):一项研究方案

Finding acute coronary syndrome with serial troponin testing for rapid assessment of cardiac ischemic symptoms (FAST-TRAC): a study protocol.

作者信息

Peacock W Frank, Maisel Alan S, Mueller Christian, Anker Stefan D, Apple Fred S, Christenson Robert H, Collinson Paul, Daniels Lori B, Diercks Deborah B, Somma Salvatore Di, Filippatos Gerasimos, Headden Gary, Hiestand Brian, Hollander Judd E, Kaski Juan C, Kosowsky Joshua M, Nagurney John T, Nowak Richard M, Schreiber Donald, Vilke Gary M, Wayne Marvin A, Than Martin

机构信息

Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, USA.

Department of Cardiology, University of California, La Jolla, CA, USA.

出版信息

Clin Exp Emerg Med. 2022 Jun;9(2):140-145. doi: 10.15441/ceem.21.154. Epub 2022 Jun 30.

Abstract

OBJECTIVE

To determine the utility of a highly sensitive troponin assay when utilized in the emergency department.

METHODS

The FAST-TRAC study prospectively enrolled >1,500 emergency department patients with suspected acute coronary syndrome within 6 hours of symptom onset and 2 hours of emergency department presentation. It has several unique features that are not found in the majority of studies evaluating troponin. These include a very early presenting population in whom prospective data collection of risk score parameters and the physician's clinical impression of the probability of acute coronary syndrome before any troponin data were available. Furthermore, two gold standard diagnostic definitions were determined by a pair of cardiologists reviewing two separate data sets; one that included all local troponin testing results and a second that excluded troponin testing so that diagnosis was based solely on clinical grounds. By this method, a statistically valid head-to-head comparison of contemporary and high sensitivity troponin testing is obtainable. Finally, because of a significant delay in sample processing, a unique ability to define the molecular stability of various troponin assays is possible.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier NCT00880802.

摘要

目的

确定高敏肌钙蛋白检测在急诊科应用时的效用。

方法

FAST-TRAC研究前瞻性纳入了1500多名在症状发作6小时内且在急诊科就诊2小时内疑似急性冠脉综合征的急诊科患者。该研究有几个大多数评估肌钙蛋白的研究中未发现的独特特征。这些特征包括一个非常早期就诊的人群,在该人群中,在任何肌钙蛋白数据可用之前,对风险评分参数进行前瞻性数据收集以及医生对急性冠脉综合征可能性的临床判断。此外,由一对心脏病专家审查两个独立数据集确定了两个金标准诊断定义;一个包括所有当地肌钙蛋白检测结果,另一个排除肌钙蛋白检测,以便诊断仅基于临床依据。通过这种方法,可以对当代和高敏肌钙蛋白检测进行具有统计学有效性的直接比较。最后,由于样本处理存在显著延迟,有可能独特地定义各种肌钙蛋白检测的分子稳定性。

试验注册

ClinicalTrials.gov标识符NCT00880802。

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