Detection of coronary artery disease with perfusion stress echocardiography using a novel ultrasound imaging agent: two Phase 3 international trials in comparison with radionuclide perfusion imaging
Detection of coronary artery disease with perfusion stress echocardiography using a novel ultrasound imaging agent: two Phase 3 international trials in comparison with radionuclide perfusion imaging
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DOI：
10.1093/ejechocard/jen321
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发表时间：
2009-01-01
影响因子：
--
通讯作者：
Picard, Michael H.
中科院分区：
文献类型：
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作者：
Senior, Roxy;Monaghan, Mark;Picard, Michael H.
目的：探讨应用Imagify(TM)(全氟丁烷聚合物微球)进行负荷超声心动图(PSE)检测冠状动脉疾病(CAD)是否与使用99m单光子发射计算机断层扫描(SPECT)负荷灌注成像进行比较。PSE是一种评价心肌血流灌注的新技术。RAMP(实时评估心肌灌注)-1和-2是国际第三阶段试验，用Imagify评估PSE检测冠心病的能力。慢性、稳定的胸痛患者(n=662)在静息和潘生丁负荷期间接受Imagify PSE和门控SPECT成像。独立盲人心脏病专家[每个试验三个PSE读取器，四个SPECT读取器(一个用于RAMP-1，三个用于RAMP-2)]]解释图像。冠心病的定义是通过定量冠状动脉造影术或结合临床回顾的90天结果。与SPECT相比，使用非劣势分析(单侧α=0.025)来评估准确性、敏感度和特异度。RAMP-1和RAMP-2的SPECT结果分别为：准确性(70%，67%)、敏感性(78%，61%)和特异性(，76%)。6种PSE阅读器的准确率均不低于SPECT(66~71%，P
To determine if perfusion stress echocardiography (PSE) with Imagify (TM) (perflubutane polymer microspheres) is comparable to stress perfusion imaging using Tc-99m single photon emission computed tomography (SPECT) for coronary artery disease (CAD) detection. PSE is a novel technique for evaluating myocardial perfusion. RAMP (real-time assessment of myocardial perfusion)-1 and -2 were international, Phase 3 trials that evaluated the ability of PSE with Imagify, to detect CAD.Chronic, stable, chest pain patients (n = 662) underwent Imagify PSE and gated SPECT imaging at rest and during dipyridamole stress. Independent blinded cardiologists [three PSE readers per trial, and four SPECT readers (one for RAMP-1, three for RAMP-2)] interpreted images. CAD was defined by quantitative coronary angiography or 90-day outcome with clinical review. Accuracy, sensitivity, and specificity were evaluated using non-inferiority analysis (one-sided alpha = 0.025) compared with SPECT. SPECT results for RAMP-1 and -2 were: accuracy (70%, 67%), sensitivity (78%, 61%), and specificity (64%, 76%). Accuracy of all six PSE readers was non-inferior to SPECT (66-71%, P