PIOPED II-DATA COORDINATING CENTER

PIOPED II 数据协调中心

• 批准号: 6527268
• 负责人: Sarah E. Fowler
• 金额: $ 67.19万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 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/6527268
• 关键词: angiography; bioimaging /biomedical imaging; clinical research; computed axial tomography; cooperative study; data management; diagnosis design /evaluation; human subject; lung imaging /visualization /scanning; noninvasive diagnosis; pulmonary circulation obstruction; ultrasonography

This is a multi-center 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 scan is the most frequently used test, but is non-diagnostic 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 enhanced 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, many physicians 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 non-diagnostic. This could lead to over treatment or under treatment, and potential serious complications. The role of spiral CT in the diagnosis of PE requires the accurate evaluation that will be made in this investigation. In response to reviewer suggestions on the original application, this revised application proposes to use a composite reference standard based on ventilation / perfusion lung scan, compression ultrasound of the lower extremities, and angiography. The strengths of the proposal are: 1) the importance of the problem of PE in terms of lives lost from under diagnosis, and major bleeding from over diagnosis; 2) the potential applicability of a new technology for the diagnosis of PE that will have widespread availability; and 3) the investigator team.

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。肺栓塞是常见的，但往往未确诊和致命的。通气/灌注扫描是最常用的检查方法，但在72%的疑似PE患者和57%的确诊PE患者中无法诊断。肺血管造影是目前明确的诊断测试，但由于发病率、不适、费用和社区医院缺乏可用性，使用它犹豫不决。对比增强螺旋CT是一种几乎无创的检查，通过显示肺动脉血栓的轮廓，为PE的明确诊断提供了可能性。然而，其在PE诊断中的应用尚不清楚。尽管螺旋CT尚未得到充分的验证，但许多医生现在将其作为PE的决定性和唯一诊断测试，或者作为通气/灌注肺扫描不能诊断的患者的决定性测试。这可能导致治疗过度或治疗不足，以及潜在的严重并发症。螺旋CT在PE诊断中的作用需要在本研究中做出准确的评估。针对审稿人对原申请的建议，本次修改后的申请提出使用基于通气/灌注肺扫描、下肢压缩超声和血管造影的复合参考标准。该提案的优势在于：1)就诊断不足导致的生命损失和过度诊断导致的大出血而言，PE问题的重要性；2) PE诊断新技术的潜在适用性，该技术将得到广泛应用；3)调查小组。