PROSPECTIVE INVESTIGATION OF PULMONARY EMBOLISM DX II

肺栓塞 DX II 的前瞻性研究

• 批准号: 6167703
• 负责人: CHARLES A HALES
• 金额: $ 22.31万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-01 至 2004-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6167703
• 关键词: angiography; bioimaging /biomedical imaging; clinical research; computed axial tomography; cooperative study; diagnosis design /evaluation; human subject; lung imaging /visualization /scanning; noninvasive diagnosis; pulmonary circulation obstruction; ultrasonography; venous thrombosis

This is a multicenter collaborative study to determine the sensitivity, specificity, positive predictive value, and negative predictive value of contrast enhanced spiral computed tomography (spiral CT) for the diagnosis of acute pulmonary embolism (PE). Pulmonary embolism is common, yet frequently undiagnosed and fatal. Ventilation/perfusion lung scans are the most commonly used test. However, they are nondiagnostic in 72 percent of patients with suspected PE, and in 57 percent of patients with proven PE. Pulmonary angiography is the currently definitive diagnostic test, but there is hesitancy to use it because of morbidity, discomfort, cost, and lack of availability in community hospitals. Contrast enhance spiral CT is a nearly noninvasive test that offers the possibility of a definitive diagnosis of PE by showing the outline of the thrombus in a pulmonary artery. However, its utility in the diagnosis of PE is unknown. Even though spiral CT has not been adequately validated, physicians at many hospitals now use it as a definitive and only diagnostic test for PE, or as a definitive test in patients in whom the ventilation/perfusion lung scan is nondiagnostic. This could lead to overtreatment or undertreatment, both of which have serious potential complications. The role of spiral CT in the diagnosis of PE requires an accurate evaluation which will be made in this investigation by comparison with pulmonary angiography. The strengths of this proposal are: 1) the importance of the problem of PE in terms of lives lost from underdiagnosis, and major bleeding from overdiagnosis 2) the potential applicability of a new technology for the diagnosis of PE that will have widespread availability and 3) the investigator team. Noninvasive leg tests, particularly venous ultrasonography, permit a strategy of management by treatment on the basis of venous thromboembolic disease (PE or deep venous thrombosis), ventilation/perfusion lung scan, or compression ultrasound of the lower extremities. Pulmonary embolism will be diagnosed on the basis of a high probability ventilation/perfusion lung scan in patients with no prior PE, pulmonary angiography, or compression ultrasound of the lower extremities in patients with no prior deep venous thrombosis. Deep venous thrombosis detected by venous ultrasound will serve as a surrogate for the diagnosis of PE. Pulmonary embolism will be excluded by pulmonary angiography, or a nearly normal or normal ventilation/perfusion lung scna with no adverse outcome (i.e. PE or DVT) on follow-up of untreated patients. Among patients with a low probability ventilation/perfusion lung scan, PE will be excluded by 2 negative venous compression ultrasound studies at 1 week intervals followed by 6 months of follow-up with no treatment and at 1 week intervals, followed by 6 months of follow-up with no treatment and no recurrent PE or DVT. The protocol parallels standard diagnostic strategy, without subjecting the patients to risk entirely for the acquisition of data.

这是一项多中心协作研究，旨在确定对比度增强螺旋计算层析成像（螺旋CT）的灵敏度，特异性，正预测值和负预测值，以诊断急性肺栓塞（PE）。肺栓塞很常见，但经常未被诊断和致命。 通风/灌注肺扫描是最常用的测试。 但是，在72％的可疑PE患者中，它们是未诊断的，有57％的患者患有PEC的患者。 肺血管造影是当前确定的诊断测试，但是由于发病率，不适，成本和社区医院缺乏可用性，因此有犹豫使用它。 对比度增强螺旋CT是一项几乎无创的测试，它通过在肺动脉中显示了血栓的轮廓，从而提供了对PE进行明确诊断的可能性。 但是，其在PE诊断中的效用尚不清楚。 即使螺旋性CT尚未得到充分验证，许多医院的医生现在将其用作PE的确定性，唯一的诊断测试，或者在通风/灌注肺扫描的患者中作为非诊断的患者进行确定的测试。 这可能导致过度治疗或不足，两者都有严重的潜在并发症。 螺旋CT在PE诊断中的作用需要进行准确的评估，这将在本研究中与肺部血管造影进行比较。 该提案的优势是：1）PE问题在诊断不足的生活中的重要性以及过度诊断的主要出血2）新技术在PE的诊断中的潜在适用性，而PE的诊断将具有广泛的可用性和3）研究人员团队。无创腿测试，尤其是静脉超声检查，允许根据静脉血栓栓塞疾病（PE或深静脉血栓形成），通风/灌注肺扫描或下肢压缩超声来通过治疗策略。 肺栓塞将根据没有先前没有先前没有深层静脉血栓形成的患者的PE，肺部血管造影或下肢压缩超声的患者的概率通气/灌注肺扫描进行诊断。 通过静脉超声检测到的深静脉血栓形成将作为诊断PE的替代物。 肺栓塞将被肺部血管造影术或几乎正常或正常的通气/灌注肺SCNA排除，而未经治疗的患者随访而没有不良预后（即PE或DVT）。 在低概率通气/灌注肺扫描的患者中，PE将以1周的间隔为2个阴性静脉压缩超声研究，然后进行6个月的随访，不进行治疗，然后进行1周的间隔，然后进行6个月的随访，没有治疗，没有经常性PE或DVT。 该协议与标准诊断策略相似，而不会使患者完全冒着数据获取数据的风险。