Mercuri M, Tang R, Phillips R M, Bond M G
Division of Vascular Ultrasound Research, Bowman Gray School of Medicine of Wake Forest University, Winston-Salem, NC, USA.
Blood Press Suppl. 1996;4:20-3.
The European Lacidipine Study on Atherosclerosis (ELSA) is a multinational interventional clinical trial aimed at determining the antiatherosclerotic effects of Lacidipine, a calcium antagonist, when compared to atenolol, a beta-blocker, on the carotid arteries of 2300 cardiovascular asymptomatic patients with moderately high blood pressure. Quantitative B-mode ultrasound imaging is being used to measure the intima-media thickness of a standardized section of the carotid arteries including the distal common, bifurcation, and proximal internal carotids. Prospective investigations of large samples of population using ultrasonographic endpoints rely heavily on the precision and reproducibility of the method. Therefore, specific quality control protocols are required to determine and monitor cross-sectional and longitudinal stability of the measurement reproducibility. In ELSA, the ultrasound methodology was specifically designed to include a set of procedures to quality control the critical components of measurement variation including instrumentation, and ultrasound operators, i.e. sonographers and readers. The ELSA clinical trial will provide the largest set of prospective quality control data on the use of quantitative B-mode ultrasound imaging.
欧洲拉西地平动脉粥样硬化研究(ELSA)是一项跨国干预性临床试验,旨在确定钙拮抗剂拉西地平与β受体阻滞剂阿替洛尔相比,对2300例心血管无症状的中度高血压患者颈动脉的抗动脉粥样硬化作用。定量B型超声成像用于测量颈动脉标准化节段的内膜中层厚度,包括颈总动脉远端、分叉处和颈内动脉近端。使用超声终点对大量人群进行前瞻性研究在很大程度上依赖于该方法的精度和可重复性。因此,需要特定的质量控制方案来确定和监测测量可重复性的横断面和纵向稳定性。在ELSA研究中,超声方法经过专门设计,包括一套程序,以对测量变异的关键组成部分进行质量控制,包括仪器设备以及超声操作人员,即超声检查医师和读数人员。ELSA临床试验将提供关于定量B型超声成像应用的最大规模的前瞻性质量控制数据。