Prospective Investigation of Pulmonary Embolism Dx III

肺栓塞 Dx III 的前瞻性研究

• 批准号: 7569733
• 负责人: JOHN G WEG
• 金额: $ 14.06万
• 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/7569733
• 关键词: Acute; Angiography; Arteries; Biological Assay; Characteristics; Chest; Clinical; Clinical assessments; Diagnosis; Diagnostic; Diagnostic Imaging; Diagnostic Procedure; Diagnostic tests; Disease; Environmental air flow; Enzymes; Exclusion Criteria; Fibrin fragment D; Gadolinium; Image; Imaging Techniques; Investigation; Ionizing radiation; Leg; Link; Lower Extremity; Lung; Magnetic Resonance; Magnetic Resonance Angiography; Outcome; Patients; Phase; Phlebography; Probability; Prospective Studies; Pulmonary Embolism; Pulmonary artery structure; Purpose; Reading; Recruitment Activity; Reference Standards; Relative (related person); Reporting; Research Design; Sensitivity and Specificity; Spiral Computed Tomography; Tachycardia; Technology Assessment; Testing; Thromboembolism; United States Agency for Healthcare Research and Quality; Venous; design; diagnostic accuracy; digital; indexing; lung imaging; prospective

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 enzyme- linked 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.

肺栓塞诊断 III 的前瞻性调查 (PIOPED-III) 是一项多中心前瞻性研究 旨在确定钆增强磁共振诊断准确性的调查 肺动脉血管造影 (Gd-MRA) 结合磁共振静脉造影 下肢（MRV）用于诊断急性静脉血栓栓塞性疾病（VTE）。这 单独使用 Gd-MRA 以及与 MRV 结合使用的诊断准确性将表示为灵敏度， 阳性和阴性测试的特异性和似然比。该研究设计是一项前瞻性研究 连续患者纳入标准化纳入/排除标准，完整确定 患者特征和结果、统一的诊断标准以及公正的配对中心读数 影像学研究。在两年的时间内，将有 1256 名临床疑似急性肺栓塞患者接受治疗。 在 7 个临床中心招募。所有患者都将接受临床指示的测试以诊断或排除肺栓塞 和静脉血栓栓塞。诊断急性 VTE 的综合参考标准包括高概率 对既往无 PE 的患者进行通气/灌注 (V/Q) 肺部扫描，采用阳性对比增强多探测器 对患有高或低血压的患者进行胸部螺旋 CT 或下肢正静脉期成像 中期客观临床评估或肺数字减影血管造影（DSA）阳性。 使用定量快速酶-低 D-二聚体将排除静脉血栓栓塞性疾病 联免疫吸附测定 (ELISA) 结合经过验证的低概率临床评估，正常 (V/Q) 肺部扫描、胸部螺旋 CT 阴性结合腿部静脉相负成像 具有低或中等客观临床 PE 可能性或肺部 DSA 阴性的患者。这是 预计 314 名患者将患有 PE 或 VTE，并将接受 Gd-MRA。预计 942 患者将被证明没有 PE 或 VTE。从该组中，将随机抽取 314 名患者 选择用于指标测试，Gd-MRA/MRV。