Prospective Investigation of Pulmonary Embolism Dx III

肺栓塞 Dx III 的前瞻性研究

• 批准号: 7499724
• 负责人: CHARLES A HALES
• 金额: $ 39.99万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 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 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7499724
• 关键词: Acute; Angiography; Arteries; Characteristics; Clinical; Diagnosis; Diagnostic; Diagnostic Imaging; Diagnostic Procedure; Diagnostic tests; Evaluation; Exclusion Criteria; Gadolinium; General Hospitals; Hemorrhage; Hospitals; Image; Imaging Techniques; Investigation; Ionizing radiation; Life; Lung; Magnetic Resonance; Magnetic Resonance Angiography; Massachusetts; Outcome; Patients; Phlebography; Prospective Studies; Protocols documentation; Pulmonary Embolism; Pulmonary artery structure; Purpose; Reading; Recruitment Activity; Reference Standards; Relative (related person); Reporting; Research Design; Research Personnel; Sensitivity and Specificity; Tachycardia; Technology; Technology Assessment; Testing; Thigh structure; United States Agency for Healthcare Research and Quality; Veins; base; design; diagnostic accuracy; indexing; lung imaging; new technology; programs; prospective; tertiary care

DESCRIPTION (provided by applicant): 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 of the pulmonary arteries (Gd-MRA) in combination with magnetic resonance venography of the veins of the thighs (MRV) in patients with clinically suspected acute pulmonary embolism (PE). This is the proposal for the Massachusetts General Hospital 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 suspected acute PE will be recruited at 7 clinical centers. Composite reference standards will be used to diagnose VTE and exclude PE. It is expected that 314 patients will have acute VTE and they will undergo Gd-MRA/MRV. It is expected that 942 patients will be shown not to have PE. From among this group, 314 patients will be randomly selected for the index test, Gd-MRA/MRV. 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 aplicability of a new technology for the diagnosis ofPE, 3) a strong investigative team that has collaborated previously in successful reaearch in PE, 4) a protocol tha\ parallels previously proven protocols for the evaluation of a diagnostic test for PE. The Massachusetts General Hospital adds to the strength of PIOPED III by showing that Gd-MRA/MRV can be used successful!} for the diiagnosis of VTE in a tertiary care hospital.

描述（由申请人提供）： 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 of the pulmonary arteries (Gd-MRA) in combination with magnetic resonance venography of the veins of the thighs (MRV) in patients with clinically suspected acute pulmonary embolism (PE).这是马萨诸塞州综合医院的建议，单独使用GD-MRA的诊断准确性，并与MRV结合使用，将表示为阳性和阴性测试的敏感性，特异性和似然比。研究设计是对连续的患者进行的前瞻性研究，这些患者纳入了标准化的包含/排除标准，完全确定患者特征和结局，统一的诊断标准以及对成像研究的无偏配对中心读数。在两年的时间里，将在7个临床中心招募1256例疑似急性PE的患者。复合参考标准将用于诊断VTE并排除PE。预计314名患者将患有急性VTE，他们将接受GD-MRA/MRV。预计将证明942名患者没有PE。从该组中，将随机选择314名患者进行指数测试，即GD-MRA/MRV。 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 aplicability of a new technology for the diagnosis ofPE, 3) a strong investigative team that has collaborated previously in successful reaearch in PE, 4) a protocol tha\ parallels previously proven protocols for the evaluation of a diagnostic test for PE.马萨诸塞州综合医院通过证明GD-MRA/MRV可以成功地使用PIOPED III的强度！