Lees R S, Pitt B, Chan R C, Holmvang G, Dinsmore R E, Campbell L W, Haber H E, Klibaner M I, Cashin-Hemphill L
Boston Heart Foundation Cambridge, Massachusetts 02142, USA.
Am J Cardiol. 1996 Nov 1;78(9):1011-6. doi: 10.1016/s0002-9149(96)00526-7.
The QUinapril Ischemic Event Trial (QUIET) is the first prospective, double-blind, placebo-controlled trial to investigate the long-term antiatherosclerotic effects of angiotensin-converting enzyme inhibition. Normotensive, nonhyperlipidemic subjects (1,750) with normal left ventricular systolic function were randomly assigned to treatment or placebo at percutaneous transluminal coronary angioplasty (PTCA). The primary end point is time to first cardiac ischemic event. Baseline clinical characteristics are (mean +/- SD): age 58 +/- 9 years; blood pressure 123 +/- 15/74 +/- 10 mm Hg; low density lipoprotein cholesterol 124 +/- 27 mg/dL; high density lipoprotein cholesterol 37 +/- 10 mg/dL; and triglycerides 167 +/- 91 mg/dL. In addition, 81% are men; 22% are current smokers; 49% give a history of myocardial infarction. Baseline angiographic characteristics are (mean +/- SD): left ventricular ejection fraction 59% +/- 11%; per patient diameter stenosis (excluding the PTCA segment) 49% +/- 31%; 8.9 +/- 3.5 analyzable segments per patient (excluding the PTCA segment), 3.8 +/- 2.3 of which have visible stenosis. Including the PTCA segment, 52% have single vessel disease and 48% have multivessel disease. Baseline angiographic data for non-PTCA segments will be correlated with cardiac ischemic events which occur after 6 months. Up to 500 subjects will undergo follow-up angiography with quantitative coronary angiographic analysis (QCA) of baseline and follow-up films. The primary QCA end point will be per-patient categorical designation as progressor or nonprogressor based on the presence or absence of > or = 400 microns narrowing in > or = 1 vessels that did not undergo PTCA.
喹那普利缺血事件试验(QUIET)是首个前瞻性、双盲、安慰剂对照试验,旨在研究血管紧张素转换酶抑制的长期抗动脉粥样硬化作用。左心室收缩功能正常的血压正常、无高脂血症的受试者(1750名)在经皮腔内冠状动脉成形术(PTCA)时被随机分配接受治疗或安慰剂。主要终点是首次心脏缺血事件的发生时间。基线临床特征为(均值±标准差):年龄58±9岁;血压123±15/74±10 mmHg;低密度脂蛋白胆固醇124±27 mg/dL;高密度脂蛋白胆固醇37±10 mg/dL;甘油三酯167±91 mg/dL。此外,81%为男性;22%为当前吸烟者;49%有心肌梗死病史。基线血管造影特征为(均值±标准差):左心室射血分数59%±11%;每位患者直径狭窄(不包括PTCA节段)49%±31%;每位患者(不包括PTCA节段)有8.9±3.5个可分析节段,其中3.8±2.3个有可见狭窄。包括PTCA节段,52%有单支血管病变,48%有多支血管病变。非PTCA节段的基线血管造影数据将与6个月后发生的心脏缺血事件相关。多达500名受试者将接受随访血管造影,并对基线和随访影像进行定量冠状动脉造影分析(QCA)。主要QCA终点将是根据未接受PTCA的≥1支血管中是否存在≥400微米的狭窄,将每位患者分类为进展者或非进展者。