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尼可地尔对接受直接经皮冠状动脉介入治疗的ST段抬高型心肌梗死患者心肌梗死面积的影响:随机对照试验的研究设计与方案

Effects of nicorandil on myocardial infarct size in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: study design and protocol for the randomized controlled trial.

作者信息

Jiang Xiao-Si, Tian Li-Chao, Jiang Zi-Chao, Zou Yu-Ting, Li Ping, Yang Xin-Chun, Su Xi, Tian Jin-Wen, Shi Bei, Li Zong-Zhuang, Li Yong-Jun, Yang Ren-Qiang, Qian Geng, Chen Yun-Dai

机构信息

Department of Cardiology, the First Medical Center of Chinese PLA General Hospital, Beijing, China.

The School of Medicine, Nankai University, Tianjin, China.

出版信息

J Geriatr Cardiol. 2020 Aug;17(8):519-524. doi: 10.11909/j.issn.1671-5411.2020.08.002.

Abstract

Previous studies have shown that nicorandil has a protective effect on cardiomyocytes. However, there is no study to investigate whether perioperative intravenous nicorandil can further reduce the myocardial infarct size in patients with ST-segment elevation myocardial infarction (STEMI) compared to the current standard of percutaneous coronary intervention (PCI) regimen. The CHANGE (China-Admini stration of Nicorandil Group) study is a multicenter, prospective, randomized, double-blind and parallel-controlled clinical study of STEMI patients undergoing primary PCI in China, aiming to evaluate the efficacy and safety of intravenous nicorandil in ameliorating the myocar dial infarct size in STEMI patients undergoing primary PCI and provide evidence-based support for myocardial protection strategies of STEMI patients.

摘要

先前的研究表明,尼可地尔对心肌细胞具有保护作用。然而,尚无研究探讨与当前经皮冠状动脉介入治疗(PCI)方案的标准相比,围手术期静脉注射尼可地尔是否能进一步缩小ST段抬高型心肌梗死(STEMI)患者的心肌梗死面积。CHANGE(中国尼可地尔给药组)研究是一项在中国对接受直接PCI的STEMI患者进行的多中心、前瞻性、随机、双盲和平行对照的临床研究,旨在评估静脉注射尼可地尔改善接受直接PCI的STEMI患者心肌梗死面积的有效性和安全性,并为STEMI患者的心肌保护策略提供循证支持。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c606/7475214/770d0f7672e8/jgc-17-8-519-1.jpg

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