Prospective Investigation of Pulmonary Embolism DX-II

肺栓塞 DX-II 的前瞻性研究

• 批准号: 6956532
• 负责人: David P Naidich
• 金额: $ 21.72万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 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 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6956532
• 关键词: adult human (21+); angiography; bioimaging /biomedical imaging; cardiovascular disorder diagnosis; cardiovascular imaging /visualization; clinical research; cooperative study; diagnosis design /evaluation; diagnosis quality /standard; diagnostic tests; gadolinium; human subject; magnetic resonance imaging; patient oriented research; pulmonary artery; pulmonary circulation; pulmonary circulation obstruction; radiodiagnosis; respiratory disorder diagnosis; respiratory imaging /visualization; thromboembolism; venography

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 (Gd-MRA) of the pulmonary arteries in combination with magnetic resonance venography (MRV) of the lower extremities for the diagnosis of acute venous thromboembolic disease (VTE). 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. All patients will undergo clinically indicated tests to diagnose or exclude PE and VTE. The composite reference standard for the diagnosis of acute VTE includes a high probability ventilation/perfusion (V/Q) lung scan in a patient with no prior PE, a positive contrast enhanced multidetector spiral CT of the chest or positive venous phase imaging of the lower extremities in a patient with a high or intermediate objective clinical assessment or a positive pulmonary digital subtraction angiogram (DSA). Venous thromboembolic disease will be excluded by a low D-dimer using the quantitative rapid enzyme-linked immunosorbent assay (ELISA) combined with a validated low probability clinical assessment, normal V/Q lung scan, negative spiral CT of the chest combined with negative venous phase imaging of the legs in a patient with a low or moderate objective clinical probability of PE, or a negative pulmonary DSA. It is expected that 314 patients will have PE or VTE and they will undergo Gd-MRA. It is expected that 942 patients will be shown to have no PE or VTE. From among this group, 314 patients will be randomly selected for the index test, Gd-MRA/MRV.

描述（由申请人提供）：