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.

这是一项多中心合作研究，旨在确定对比增强螺旋计算机断层扫描（螺旋 CT）诊断急性肺栓塞（PE）的敏感性、特异性、阳性预测值和阴性预测值。肺栓塞很常见，但常常未被诊断且致命。 通气/灌注肺部扫描是最常用的测试。 然而，对于 72% 的疑似肺栓塞患者和 57% 的确诊肺栓塞患者，它们无法诊断。 肺血管造影是目前确定的诊断测试，但由于发病率、不适、成本以及社区医院缺乏可用性，人们对使用它犹豫不决。 对比增强螺旋 CT 是一种几乎无创的检查，通过显示肺动脉中血栓的轮廓，提供了 PE 明确诊断的可能性。 然而，其在 PE 诊断中的效用尚不清楚。 尽管螺旋 CT 尚未得到充分验证，但许多医院的医生现在将其用作肺栓塞的明确且唯一的诊断测试，或者作为通气/灌注肺扫描无法诊断的患者的明确测试。 这可能导致过度治疗或治疗不足，这两种情况都有严重的潜在并发症。 螺旋CT在PE诊断中的作用需要准确评估，本研究将通过与肺血管造影进行比较来进行评估。 该提案的优点是： 1) PE 问题的重要性，即因诊断不足而造成的生命损失，以及因过度诊断而造成的大出血 2) 广泛使用的诊断 PE 的新技术的潜在适用性 3) ）调查组。无创腿部测试，特别是静脉超声检查，允许通过基于静脉血栓栓塞性疾病（PE或深静脉血栓形成）、通气/灌注肺部扫描或下肢加压超声的治疗来制定管理策略。 肺栓塞的诊断将基于对既往无 PE 的患者进行高概率通气/灌注肺部扫描、肺血管造影或对既往无深静脉血栓形成的患者进行下肢加压超声检查。 静脉超声检测到的深静脉血栓形成将作为 PE 诊断的替代指标。 肺栓塞将通过肺血管造影排除，或者在对未经治疗的患者进行随访时，肺血管造影几乎正常或正常通气/灌注，没有不良后果（即PE或DVT）。 在进行低概率通气/灌注肺扫描的患者中，将通过 2 项负静脉压迫超声研究（间隔 1 周，随后进行 6 个月的随访，不进行治疗）和间隔 1 周的随访，随后进行 6 个月的随访，排除 PE无需治疗，也没有复发 PE 或 DVT。 该协议与标准诊断策略类似，不会让患者因数据采集而完全面临风险。