Hole T, Otterstad J E, St John Sutton M, Frøland G, Holme I, Skjaerpe T
Division of Cardiology, Medical Department, Central Hospital Møre and Romsdal, Alesund, Norway.
Eur J Echocardiogr. 2002 Dec;3(4):263-70.
To examine differences in measurements of left ventricular dimensions and function, and prognostic value between local investigators and a core laboratory in a multicentre serial echocardiographic study.
Seven hundred and fifty-six patients with acute myocardial infarction and preserved left ventricular function were examined at baseline and after 3 months with measurements by the biplane Simpson's method, and followed prospectively from 3 to 24 months. At baseline and 3 months local investigators relative to the core laboratory measured lesser end-diastolic volume by 8 and 6 ml (P<0.001), end-systolic volume by 3 and 2 ml (P<0.01), and ejection fraction by 0.0 and 0.6% (P<0.01), respectively. Local investigators and the core laboratory measured an increase in left ventricular end-diastolic volume of 8.6 and 6.9 ml, and in left ventricular end-systolic volume of 5.2 and 4.3 ml, and a decrease in left ventricular ejection fraction of 0.6 and 0.0%. Using the Cox proportionate hazards model, the prognostic value for subsequent clinical endpoints was significant both for the 3-month values (P<0.05) and changes (P<0.005) measured by the core laboratory, but not by local investigators.
Only measurements in the core laboratory had significant prognostic value for subsequent clinical endpoints. These results strongly support the use of a core laboratory in studies employing echocardiographic measurements.
在一项多中心系列超声心动图研究中，探讨本地研究人员与核心实验室在左心室尺寸和功能测量方面的差异以及预后价值。
756例急性心肌梗死且左心室功能保留的患者在基线时和3个月后接受了测量，采用双平面辛普森法，并对其进行了3至24个月的前瞻性随访。在基线和3个月时，相对于核心实验室，本地研究人员测得的舒张末期容积分别少8 ml和6 ml（P<0.001），收缩末期容积分别少3 ml和2 ml（P<0.01），射血分数分别低0.0%和0.6%（P<0.01）。本地研究人员和核心实验室测得左心室舒张末期容积增加量分别为8.6 ml和6.9 ml，左心室收缩末期容积增加量分别为5.2 ml和4.3 ml，左心室射血分数降低量分别为0.6%和0.0%。使用Cox比例风险模型，核心实验室测得的3个月时的值（P<0.05）和变化量（P<0.005）对后续临床终点具有显著的预后价值，而本地研究人员测得的则无。
仅核心实验室的测量结果对后续临床终点具有显著的预后价值。这些结果有力地支持了在采用超声心动图测量的研究中使用核心实验室。
