Prospective Investigation of Pulmonary Embolism DX-III

肺栓塞 DX-III 的前瞻性研究

• 批准号: 6956977
• 负责人: Pamela K Woodard
• 金额: $ 17.71万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-01 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6956977
• 关键词: adult human (21+); angiography; bioimaging /biomedical imaging; cardiovascular disorder diagnosis; cardiovascular imaging /visualization; clinical research; cooperative study; diagnosis design /evaluation; diagnosis quality /standard; diagnostic tests; gadolinium; human subject; magnetic resonance imaging; patient oriented research; pulmonary artery; pulmonary circulation; pulmonary circulation obstruction; radiodiagnosis; respiratory disorder diagnosis; respiratory imaging /visualization; thromboembolism; venography

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.

描述（由申请人提供）： （PIOPED FFL）对肺栓塞诊断的前瞻性研究是一项多中心前瞻性研究，旨在对急性肺栓塞诊断（PE）诊断的Gadolinium增强磁共振血管造影（MRA）的敏感性和特异性进行定量评估。该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果，统一的诊断标准以及对成像研究的无偏中央阅读。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。所有患者将接受临床指示的测试以诊断或排除PE。这包括经过验证的临床评估，通过快速酶联免疫吸附测定（ELIS A），下肢的压缩超声，通风/灌注（V/Q）肺扫描，对比增强螺旋计算机摄影（CT），最终可能包括肺部数字亚摘要Angiographic（DSA）。预计317名患者将患有PE，他们将接受Gadolinium增强的MRA。预计将证明939名患者没有PE。从没有PE的组中，将有317名患者进行MRA（以及静脉超声）。所有用于诊断或排除PE的MRA图像和患有MRA的PE的所有图像将由两名读者发送盲目的中央读数。