奥美沙坦酯对冠状动脉计算机断层扫描血管造影检测的冠状动脉粥样硬化患者冠状动脉粥样硬化进展及心外膜脂肪组织体积减少的疗效研究：一项随机对照试验的研究方案
Efficacy study of olmesartan medoxomil on coronary atherosclerosis progression and epicardial adipose tissue volume reduction in patients with coronary atherosclerosis detected by coronary computed tomography angiography: study protocol for a randomized controlled trial.
作者信息
Zhou Ying, Tian Feng, Wang Jing, Yang Jun-Jie, Zhang Tao, Jing Jing, Chen Yun-Dai
机构信息
Department of Cardiology, Chinese PLA General Hospital, Beijing, 100853, China.
出版信息
Trials. 2016 Jan 6;17:10. doi: 10.1186/s13063-015-1097-z.
BACKGROUND
Epicardial adipose tissue (EAT) is a newly discovered independent risk factor for coronary atherosclerosis. There is a scarcity of information on the reduction of EAT volume to reduce atherosclerosis risk. Coronary computed tomography angiography (CCTA) has emerged as a noninvasive imaging method for the analysis of coronary atherosclerosis and EAT volume. The purpose of this trial is to determine whether olmesartan medoxomil is effective at both treatment of coronary atherosclerosis progression and EAT volume reduction in patients with coronary atherosclerosis detected by CCTA.
METHODS/DESIGN: This study is a prospective, single-center, open-label, randomized controlled clinical trial aimed at exploring the efficacy of olmesartan medoxomil on coronary atherosclerosis and EAT. A total of 194 patients with coronary stenosis greater than 30 % and less than 70 % detected by CCTA will be randomly divided into olmesartan medoxomil or conventional antihypertensive medication groups (1:1 ratio). The primary outcome measures include coronary atherosclerosis progression and EAT volume reduction, as detected by CCTA at 12 months. The secondary outcome measures include the levels of blood lipids, glucose, high-sensitivity C-reactive protein, IL-6, monocyte chemotactic protein 1, TNF-α, matrix metalloproteinase 9, NO, endothelin 1, adiponectin, and leptin at baseline and after 6 and 12 months.
DISCUSSION
Treatments aimed at reducing EAT volume can eventually achieve an antiatherosclerotic effect. This is the first trial designed to explore the effect of olmesartan medoxomil on both coronary atherosclerosis progression and EAT volume reduction in patients with coronary atherosclerosis detected by CCTA.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT02360956 .
背景
心外膜脂肪组织（EAT）是新发现的冠状动脉粥样硬化独立危险因素。关于通过减少EAT体积来降低动脉粥样硬化风险的信息较少。冠状动脉计算机断层扫描血管造影（CCTA）已成为一种用于分析冠状动脉粥样硬化和EAT体积的非侵入性成像方法。本试验的目的是确定奥美沙坦酯在治疗CCTA检测出的冠状动脉粥样硬化患者的冠状动脉粥样硬化进展和减少EAT体积方面是否有效。
方法/设计：本研究是一项前瞻性、单中心、开放标签、随机对照临床试验，旨在探索奥美沙坦酯对冠状动脉粥样硬化和EAT的疗效。总共194例CCTA检测出冠状动脉狭窄大于30%且小于70%的患者将被随机分为奥美沙坦酯组或传统抗高血压药物组（1:1比例）。主要结局指标包括12个月时CCTA检测到的冠状动脉粥样硬化进展和EAT体积减少。次要结局指标包括基线时以及6个月和12个月后的血脂、血糖、高敏C反应蛋白、IL-6、单核细胞趋化蛋白1、TNF-α、基质金属蛋白酶9、NO、内皮素1、脂联素和瘦素水平。
讨论
旨在减少EAT体积的治疗最终可实现抗动脉粥样硬化作用。这是第一项旨在探索奥美沙坦酯对CCTA检测出的冠状动脉粥样硬化患者的冠状动脉粥样硬化进展和EAT体积减少两方面影响的试验。
试验注册
ClinicalTrials.gov：NCT02360956 。
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