Prospective Investigation of Pulmonary Embolism Dx III

描述(由申请人提供)： 肺栓塞诊断III期前瞻性研究(PIOPED III)是一项多中心前瞻性研究，旨在确定Gd-MRA结合大腿静脉磁共振静脉成像(MRV)对临床疑似急性肺栓塞(PE)患者的诊断准确性。这是对管理中心的建议，它包含了PIOPED III的科学部分。Gd-MRA单独和结合MRV的诊断准确性将以敏感性、特异性和阳性和阴性测试的似然比来表示。这项研究设计是一项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无偏见的成对成像研究中心读数。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。综合参考标准将用于诊断VTE和排除PE。预计将有314名患者发生急性VTE，他们将接受Gd-MRA/MRV。预计将有942名患者被证明没有PE。从这组患者中随机选择314名患者进行Gd-MRA/MRV指数测试。这一建议的优点是：1)从诊断不足和过度诊断造成的大出血造成的生命损失的角度来看，PE问题的重要性，2)PE诊断新技术的潜在适用性，3)以前在PE成功研究中合作的强大调查团队，4)与先前证明的PE诊断测试评估方案相平行的方案。

DESCRIPTION (provided by applicant): The Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III) is a multicenter prospective investigation designed to determine the diagnostic accuracy of gadolinium enhanced magnetic resonance angiography of the pulmonary arteries (Gd-MRA) in combination with magnetic resonance venography of the veins of the thighs (MRV) in patients with clinically suspected acute pulmonary embolism (PE). This is the proposal for the Administrative Center, and it contains the scientific portion of PIOPED III. The diagnostic accuracy of Gd-MRA alone and in combination with MRV will be expressed as sensitivity, specificity, and likelihood ratio for positive and negative tests. 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 paired central readings of imaging studies. Over a period of two years, 1256 patients with suspected acute PE will be recruited at 7 clinical centers. Composite reference standards will be used to diagnose VTE and exclude PE. It is expected that 314 patients will have acute VTE and they will undergo Gd-MRA/MRV. It is expected that 942 patients will be shown not to have PE. From among this group, 314 patients will be randomly selected for the index test, Gd-MRA/MRV. The strengths of this proposal are: 1) the importance of the problem of PE in terms of lives lost from under diagnosis and major bleeding from over diagnosis, 2) the potential applicability of a new technology for the diagnosis of PE, 3) a strong investigative team that has collaborated previously in successful research in PE, 4) a protocol that parallels previously proven protocols for the evaluation of a diagnostic test for PE.