PROSPECTIVE INVESTIGATION OF PULMONARY EMBOLISM DX-II

(摘自申请者的摘要)这是一项多中心合作研究，旨在确定对比增强螺旋CT(螺旋CT)诊断急性肺栓塞(PE)的敏感性、特异性、阳性和阴性预测价值。肺栓塞是一种常见的疾病，但经常未被诊断并致死。螺旋CT是一种近乎非侵入性的检查，通过显示肺动脉血栓的轮廓，提供了明确诊断PE的可能性。然而，它在PE的诊断中的作用尚不清楚。尽管螺旋CT还没有得到充分的验证，但许多医院的医生现在把它作为一种决定性的、唯一的诊断测试。这可能导致过度治疗或治疗不足，两者都有严重的潜在并发症。螺旋CT在PE诊断中的作用需要通过包括肺血管造影、肺通气/灌注扫描、静脉压迫超声和结果分析在内的综合诊断试验进行准确的评估。这项建议的优点是：1)就诊断不足和过度诊断造成的大出血造成的生命损失而言，PE问题的重要性；2)一种诊断PE的新技术的潜在适用性，该技术将得到广泛的应用；3)该方案与标准诊断策略类似，而不会让患者为获取数据而完全冒风险；4)调查团队强大，以前曾在PE方面进行过成功的研究。

(Adapted from the applicant's abstract) This is a multicenter collaborative study to determine the sensitivity, specificity, positive 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. 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. 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 a composite of diagnostic tests including pulmonary angiography, ventilation/perfusion lung scans, venous compression ultrasound, and outcome analysis. 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; 3) the protocol parallels standard diagnostic strategy without subjecting the patients to risk entirely for the acquisition of data and 4) the team of investigators is strong and has collaborated previously in successful research in PE.