Prospective Investigation of Pulmonary Embolism DX-III

描述（由申请人提供）： 肺栓塞诊断的前瞻性研究（PIOPED ffl）是一项多中心前瞻性研究，旨在定量评估钆增强磁共振血管造影（MRA）诊断急性肺栓塞（PE）的敏感性和特异性。研究设计是一项前瞻性研究，纳入了标准化的纳入/排除标准、患者特征和结局的完全确定、统一的诊断标准和无偏倚的影像学研究中心阅读。在两年的时间内，将在7个临床中心招募1256例疑似急性PE患者。所有患者都将接受有临床指征的检查，以诊断或排除PE。这包括经验证的临床评估、通过快速酶联免疫吸附试验（ELISA）进行的D-二聚体、下肢加压超声、通气/灌注（V/Q）肺扫描、对比增强螺旋计算机断层扫描（CT），最终可能包括肺数字减影血管造影（DSA）。预计将有317名患者发生PE，他们将接受钆增强MRA。预计939例患者将显示无PE。在无PE的该组中，317例患者将随机接受MRA（以及静脉超声）。所有MRA图像和所有用于诊断或排除接受MRA的患者PE的图像将由两名阅片人发送至设盲中心进行阅片。

DESCRIPTION (provided by applicant): The Prospective Investigation of Pulmonary Embolism Diagnosis in (PIOPED ffl) is a multicenter prospective investigation designed to give a quantitative assessment of the sensitivity and specificity of gadolinium enhanced magnetic resonance angiography (MRA) for the diagnosis of acute pulmonary embolism (PE). The study design is a prospective study of consecutive patients incorporating standardized inclusion/exclusion criteria, complete ascertainment of patient characteristics and outcomes, uniform diagnostic criteria, and unbiased central reading of imaging studies. Over a period of two years, 1256 patients with suspected acute PE will be recruited at 7 clinical centers. All patients will undergo clinically indicated tests to diagnose or exclude PE. This includes a validated clinical assessment, D-dimer by rapid enzyme-linked immunosorbent assay (ELIS A), compression ultrasound of the lower extremities, ventilation/perfusion (V/Q) lung scan, contrast enhanced spiral computed tomography (CT), and ultimately may include pulmonary digital subtraction angiography (DSA). It is expected that 317 patients will have PE and they will undergo gadolinium enhanced MRA. It is expected that 939 patients will be shown to have no PE. From among this group with no PE, 317 patients will be randomized for MRA (and venous ultrasound as well). All MRA images and all images used for the diagnosis or exclusion of PE in patients who had an MRA will be sent for blinded central readings by two readers.