联合检测 copeptin 与高敏心肌肌钙蛋白 T 在早期急性心肌梗死中的诊断价值：一项随机双盲诊断试验方案。
Diagnostic value of copeptin combined with hypersensitive cardiac troponin T detection in early acute myocardial infarction: A protocol of randomized double-blind diagnostic trial.
机构信息
Department of Cardiovascular Medicine, Heilongjiang Provincial Hospital, Harbin, Heilongjiang Province, China.
出版信息
Medicine (Baltimore). 2021 Jan 8;100(1):e23949. doi: 10.1097/MD.0000000000023949.
BACKGROUND
The sensitivity and specificity of the routine detection of acute myocardial infarction (AMI) in early diagnosis are not high, which can not meet the clinical needs. Copeptin combined with hypersensitive cardiac troponin T (hs-cTnT) is a new detection scheme, and its value in the early diagnosis of acute myocardial infarction is still unclear. Accordingly, the aim of this study is to evaluate the diagnostic value of copeptin combined with hypersensitive troponin T detection in early acute myocardial infarction.
METHODS
This is a prospective, randomized; double-blind diagnostic trial to investigate the diagnostic value of copeptin combined with hypersensitive troponin T detection in early acute myocardial infarction. Approved by the clinical research ethics of our hospital. Patients were randomly divided into one of 2 test protocols: (A) copeptin combined with hs-cTnT group and (B) cardiac troponin I (cTnI) group. Patients, doctors, nurses, inspectors, and data-gathering assistants were blinded to group allocation. We will focus on the sensitivity comparison of the 2 detection methods at different time periods and the sensitivity and specificity comparison of the two detection methods. Data were analyzed using the statistical software package SPSS version 25.0 (Chicago, IL).
DISCUSSION
The purpose of this study is to evaluate the diagnostic value of copeptin combined with hypersensitive cardiac troponin T detection in early acute myocardial infarction. The results of this study will establish clinical evidence for the detection of high sensitivity cardiac troponin T in the early diagnosis of acute myocardial infarction.
ETHICS AND DISSEMINATION
Private information from individuals will not be published. This systematic review also does not involve endangering participant rights. Ethical approval was not required. The results may be published in a peer-reviewed journal or disseminated at relevant conferences.
OSF REGISTRATION NUMBER
DOI 10.17605/OSF.IO/6TE5Z.
背景
常规检测急性心肌梗死（AMI）在早期诊断中的灵敏度和特异性不高，不能满足临床需求。 copeptin 联合高敏心肌肌钙蛋白 T（hs-cTnT）是一种新的检测方案，但其在急性心肌梗死早期诊断中的价值尚不清楚。因此，本研究旨在评估 copeptin 联合高敏肌钙蛋白 T 检测在急性心肌梗死早期诊断中的诊断价值。
方法
这是一项前瞻性、随机、双盲诊断试验，旨在研究 copeptin 联合高敏肌钙蛋白 T 检测在急性心肌梗死早期诊断中的诊断价值。该研究获得了我院临床研究伦理委员会的批准。患者被随机分为以下 2 种检测方案之一：（A）copeptin 联合 hs-cTnT 组和（B）心肌肌钙蛋白 I（cTnI）组。患者、医生、护士、检查人员和数据收集助手均对分组情况不知情。我们将重点关注两种检测方法在不同时间段的灵敏度比较，以及两种检测方法的灵敏度和特异性比较。数据分析采用 SPSS 25.0 统计软件包（芝加哥，IL）。
讨论
本研究旨在评估 copeptin 联合高敏心肌肌钙蛋白 T 检测在急性心肌梗死早期诊断中的诊断价值。本研究的结果将为高敏心肌肌钙蛋白 T 在急性心肌梗死早期诊断中的检测提供临床证据。
伦理和传播
不会公布个人的隐私信息。本系统评价也不会危及参与者的权利。本研究不需要伦理批准。研究结果可能会发表在同行评议的期刊上，或在相关会议上传播。
OSF 注册号：DOI 10.17605/OSF.IO/6TE5Z。
Zotero 插件