Prospective Investigation for Pulmonary Embolism Dx III

肺栓塞 Dx III 的前瞻性调查

• 批准号: 6957163
• 负责人: DANIEL J SAK
• 金额: $ 15.42万
• 依托单位: ST. JOSEPH MERCY OAKLAND
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-05 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6957163
• 关键词: angiography; bioimaging /biomedical imaging; cardiovascular disorder diagnosis; cardiovascular imaging /visualization; clinical research; cooperative study; diagnosis design /evaluation; diagnosis quality /standard; human subject; magnetic resonance imaging; patient oriented research; pulmonary artery; pulmonary circulation obstruction; venography

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.

描述（由申请人提供）： 肺栓塞诊断III（PIOPED III）的前瞻性研究是一种前瞻性|研究旨在确定肺动脉动脉（GD-MRA）增强磁共振血管造影的诊断精度，并在临床疑问急性疑问的急性肺栓塞（PE）的患者大腿静脉（MRV）的磁共振静脉曲张结合使用。这是圣约瑟夫·梅西·奥克兰斜角中心的提议。单独和与MRV结合使用GD-MRA的诊断准确性将表示为阳性和阴性测试的灵敏度，特异性和似然比。研究设计是对连续的患者进行的前瞻性研究，这些患者纳入了标准化的包含/排除标准，完全确定患者特征和结局，统一的诊断标准以及对成像研究的无偏配对中心读数。在两年的时间里，将在7个临床中心招募1256例疑似急性PE的患者。复合参考标准将用于诊断VTE并排除PE。预计314名患者将患有急性VTE，他们将接受GD-MRA/MRV。预计将证明942名患者没有PE。从该组中，将随机选择314名患者进行指数测试，即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.圣约瑟夫·梅西·奥克兰（St. Joseph Mercy Oakland）临床中心通过证明GD-MRA/MRV可以成功地用于非大学医院的VTE二诊断，从而增加了PIOPED III的强度。