Prospective Investigation for 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结合股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。这是圣约瑟夫·梅西·奥克兰临床中心的提案。Gd-MRA单独和联合MRV的诊断准确性将表现为对阳性和阴性试验的敏感性、特异性和似然比。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)PE问题在诊断失误和过度诊断造成的大出血方面的重要性，2)诊断PE的新技术的潜在可应用性，3)以前在PE成功研究中合作的强大的调查团队，4)与先前证实的PE诊断测试评估方案相平行的方案。圣约瑟夫慈悲奥克兰临床中心通过展示Gd-MRA/MRV可以成功地用于非大学医院的VTE诊断，增加了PIOPED III的力量。

DESCRIPTION (provided by applicant): The Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III) is a rnulticenter 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 St.Joseph Mercy Oakland Clincial Center. 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 ofPE in terms of lives lost from undem'iagnosis and major bleeding from overdiagnosis, 2) the potential aplicability of a new technology for the diagnosis of PE-, 3) a strong investigative team that has collaborated previously in successful reaearch in PE, 4) a protocol that parallels previously proven protocols for the evaluation of a diagnostic test for PE. The St. Joseph Mercy Oakland Clinical Center adds to the strength of PIOPED III by showing that Gd-MRA/MRV can be used successfully for the diiagnosis of VTE in a nonuniversity hospital.