Department of Cardiology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine.
Department of Cardiology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.
Medicine (Baltimore). 2021 Mar 12;100(10):e24944. doi: 10.1097/MD.0000000000024944.
The morbidity and mortality of acute myocardial infarction patients still remains high after percutaneous coronary intervention (PCI). Myocardial ischemia-reperfusion (MIR) injury is one of the important reasons. Although the phenomenon of MIR injury can paradoxically reduce the beneficial effects of myocardial reperfusion, there currently remains no effective therapeutic agent for preventing MIR. Previous studies have shown that Yiqi Liangxue Shengji prescription (YLS) is effective in improving clinical symptoms and ameliorating the major adverse cardiovascular events of coronary heart disease patients undergoing PCI. This study aims to evaluate the effectiveness and safety of YLS in patients with acute myocardial infarction (AMI) after PCI.
This study is a randomized, double-blinded, placebo-controlled, single-central clinical trial. A total of 140 participants are randomly allocated to 2 groups: the intervention group and the placebo group. Based on routine medications, the intervention group will be treated with YLS and the placebo group will be treated with YLS placebo. All participants will receive a 8-week treatment and then be followed up for another 12 months. The primary outcome measures are N terminal pro B type natriuretic peptide (NT-proBNP) and left ventricular ejection fraction. Secondary outcomes are plasma levels of microRNA-145, plasma cardiac enzyme, and Troponin I levels in blood samples, changes in ST-segment in ECG, Seattle Angina Questionnaire, the efficacy of angina symptoms, and occurrence of major adverse cardiac events. All the data will be recorded in case report forms and analyzed by SPSS V.17.0.
The trial will investigate whether the postoperative administration of YLS in patients with AMI after PCI will improve cardiac function. And it explores microRNAs (miRNA)-145 as detection of blood-based biomarkers for AMI by evaluating the relation between miRNAs in plasma and cardiac function.
Chinese Clinical Trials Registry identifier ChiCTR2000038816. Registered on October 10, 2020.
经皮冠状动脉介入治疗（PCI）后急性心肌梗死（AMI）患者的发病率和死亡率仍然很高。心肌缺血再灌注（MIR）损伤是重要原因之一。虽然 MIR 损伤现象可能会使心肌再灌注的有益作用适得其反，但目前尚无预防 MIR 的有效治疗药物。既往研究表明，益气凉血生肌方（YLS）对改善冠心病 PCI 术后患者的临床症状和改善主要不良心血管事件有效。本研究旨在评估 YLS 对 PCI 后 AMI 患者的有效性和安全性。
本研究为随机、双盲、安慰剂对照、单中心临床试验。共纳入 140 名参与者，随机分为 2 组：干预组和安慰剂组。在常规药物治疗的基础上，干预组给予 YLS 治疗，安慰剂组给予 YLS 安慰剂。所有参与者均接受 8 周的治疗，然后再随访 12 个月。主要结局指标为 N 末端 pro B 型利钠肽（NT-proBNP）和左心室射血分数。次要结局指标为血浆 microRNA-145 水平、血浆心肌酶和血液样本中的肌钙蛋白 I 水平、心电图 ST 段变化、西雅图心绞痛问卷、心绞痛症状的疗效以及主要不良心脏事件的发生情况。所有数据均记录在病例报告表中，并采用 SPSS V.17.0 进行分析。
本试验将研究 PCI 后 AMI 患者术后应用 YLS 是否会改善心功能。并通过评估血浆中 miRNA 与心功能的关系，探讨 microRNAs（miRNA）-145 作为 AMI 基于血液的生物标志物的检测。
中国临床试验注册中心标识符 ChiCTR2000038816。于 2020 年 10 月 10 日注册。
