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Gd增强磁共振血管成像(MRA)诊断急性肺栓塞(PE)的敏感性和特异性。这项研究设计是一项针对连续患者的前瞻性研究，包括标准化的纳入/排除标准、完全确定患者的特征和结果、统一的诊断标准以及对成像研究的无偏见的集中阅读。在两年的时间里，将在7个临床中心招募1256名疑似急性PE患者。所有患者都将接受临床指定的检查，以诊断或排除PE。这包括经过验证的临床评估、快速酶联免疫吸附试验(ELIS A)的D-二聚体、下肢超声、呼吸/灌注(V/Q)肺扫描、对比增强螺旋CT(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Gd增强MRA。预计将有939名患者被证明没有PE。在这组没有PE的患者中，317名患者将被随机进行MRA(以及静脉超声)。所有MRA图像和所有用于诊断或排除有MRA的患者的PE的图像将由两个阅读器发送用于盲目中心读数。

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.