Prospective Investigation of Pulmonary Embolism Dx III

肺栓塞 Dx III 的前瞻性研究

• 批准号: 6956607
• 负责人: JOHN G WEG
• 金额: $ 25.46万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 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/6956607
• 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 III (PIOPED-III) is a multicenter prospective investigation designed to determine the diagnostic accuracy of gadolinium enhanced magnetic resonance angiography (Gd-MRA) of the pulmonary arteries in combination with magnetic resonance venography (MRV) of the lower extremities for the diagnosis of acute venous thromboembolic disease (VTE). 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 clinically suspected acute PE will be recruited at 7 clinical centers. All patients will undergo clinically indicated tests to diagnose or exclude PE and VTE. The composite reference standard for the diagnosis of acute VTE includes a high probability ventilation/perf usion (V/Q) lung scan in a patient with no prior PE, a positive contrast enhanced multidetector spiral CT of the chest or positive venous phase imaging of the lower extremities in a patient with a high or intermediate objective clinical assessment or a positive pulmonary digital subtraction angiogram (DSA). Venous thromboembolic disease will be excluded by a low D-dimer using the quantitative rapid enzymelinked immuosorbent assay (ELISA) combined with a validated low probability clinical assessment, normal (V/Q) lung scan, negative spiral CT of the chest combined with negative venous phase imaging of the legs in a patient with a low or moderate objective clinical probability of PE, or a negative pulmonary DSA. It is expected that 314 patients will have PE or VTE and they will undergo Gd-MRA. It is expected that 942 patients will be shown to have no PE or VTE. From among this group, 314 patients will be randomly selected for the index test, Gd-MRA/MRV.

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，旨在确定肺动脉钆增强磁共振血管造影 (Gd-MRA) 与肺动脉磁共振静脉造影 (MRV) 相结合的诊断准确性。下肢用于诊断急性静脉血栓栓塞性疾病（VTE）。单独使用 Gd-MRA 以及与 MRV 结合使用的诊断准确性将表示为阳性和阴性检测的敏感性、特异性和似然比。该研究设计是一项对连续患者进行的前瞻性研究，纳入了标准化的纳入/排除标准、患者特征和结果的完整确定、统一的诊断标准以及影像学研究的无偏倚配对中心读数。两年内，7 个临床中心将招募 1256 名临床疑似急性肺栓塞患者。所有患者都将接受临床指示测试以诊断或排除 PE 和 VTE。诊断急性 VTE 的综合参考标准包括对既往无 PE 的患者进行高概率通气/灌注 (V/Q) 肺部扫描、胸部阳性对比增强多排螺旋 CT 或胸部正静脉期成像。具有高或中级客观临床评估或肺数字减影血管造影 (DSA) 阳性的患者的下肢。使用定量快速酶联免疫吸附测定 (ELISA) 结合经过验证的低概率临床评估，通过低 D-二聚体排除静脉血栓栓塞性疾病，正常 (V/Q) 肺部扫描，胸部螺旋 CT 阴性，腿部静脉相成像阴性，客观临床 PE 可能性低或中等，或肺部 DSA 阴性。预计 314 名患者将患有 PE 或 VTE，并将接受 Gd-MRA。预计 942 名患者将被证明没有 PE 或 VTE。从该组中，将随机选择 314 名患者进行 Gd-MRA/MRV 指标测试。