Prospective Investigation of Pulmonary Embolism DX-II

肺栓塞 DX-II 的前瞻性研究

• 批准号: 7499725
• 负责人: David P Naidich
• 金额: $ 40.58万
• 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 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7499725
• 关键词: Acute; Angiography; Characteristics; Chest; Clinical; Clinical assessments; Diagnosis; Diagnostic; Disease; Environmental air flow; Enzyme-Linked Immunosorbent Assay; Exclusion Criteria; Fibrin fragment D; Gadolinium; Image; Investigation; Leg; Lower Extremity; Lung; Magnetic Resonance; Magnetic Resonance Angiography; Outcome; Patients; Perfusion; Phase; Phlebography; Probability; Prospective Studies; Pulmonary Embolism; Pulmonary artery structure; Reading; Recruitment Activity; Reference Standards; Research Design; Sensitivity and Specificity; Spiral Computed Tomography; Testing; Venous; design; diagnostic accuracy; digital; indexing; lung imaging; prospective

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)： 肺栓塞诊断的前瞻性研究III(PIOPED III)是一项多中心前瞻性研究，旨在确定肺动脉Gd-MRA增强磁共振血管成像(Gd-MRA)与下肢磁共振静脉成像(MRV)联合诊断急性静脉血栓栓塞病(VTE)的准确性。Gd-MRA单独和联合MRV的诊断准确性将表现为对阳性和阴性试验的敏感性、特异性和似然比。这项研究设计是一项对连续患者的前瞻性研究，包括标准化的纳入/排除标准、完全确定患者的特征和结果、统一的诊断标准以及无偏见的成对成像研究中心读数。在两年的时间里，将在7个临床中心招募1256名疑似急性PE患者。所有患者都将接受临床指定的测试，以诊断或排除PE和VTE。诊断急性静脉血栓栓塞症的综合参考标准包括：无肺血栓栓塞史的患者行高概率肺通气/灌注(V/Q)扫描，临床评价高或中等客观指标或肺数字减影血管造影(DSA)阳性的患者行胸部多层螺旋CT增强扫描，或双侧肢体静脉期显像阳性。静脉血栓栓塞症将通过低D-二聚体的定量快速酶联免疫吸附试验(ELISA)结合有效的低概率临床评估、正常的V/Q肺部扫描、胸部螺旋CT阴性结合腿部静脉期成像阴性的患者来排除，这些患者的客观临床概率为低或中等，或者肺DSA阴性。预计将有314名患者发生PE或VTE，他们将接受Gd-MRA检查。预计942名患者将被证明没有PE或VTE。从这组患者中随机选择314名患者进行Gd-MRA/MRV指数测试。

项目成果

Gadolinium-enhanced magnetic resonance angiography for pulmonary embolism: a multicenter prospective study (PIOPED III).

• DOI: 10.7326/0003-4819-152-7-201004060-00008
• 发表时间: 2010-04-06
• 期刊: Annals of internal medicine
• 影响因子: 39.2
• 作者: Stein PD;Chenevert TL;Fowler SE;Goodman LR;Gottschalk A;Hales CA;Hull RD;Jablonski KA;Leeper KV Jr;Naidich DP;Sak DJ;Sostman HD;Tapson VF;Weg JG;Woodard PK;PIOPED III (Prospective Investigation of Pulmonary Embolism Diagnosis III) Investigators
• 通讯作者: PIOPED III (Prospective Investigation of Pulmonary Embolism Diagnosis III) Investigators

Signal quality of single dose gadobenate dimeglumine pulmonary MRA examinations exceeds quality of MRA performed with double dose gadopentetate dimeglumine.

单剂量钆喷酸二葡胺肺部 MRA 检查的信号质量超过双剂量钆喷酸二葡胺进行的 MRA 检查的信号质量。

• DOI: 10.1007/s10554-011-9821-6
• 发表时间: 2012
• 期刊: The international journal of cardiovascular imaging
• 作者: Woodard,PamelaK;Chenevert,ThomasL;Sostman,HDirk;Jablonski,KathleenA;Stein,PaulD;Goodman,LawrenceR;Londy,FrankJ;Narra,Vamsidhar;Hales,CharlesA;Hull,RussellD;Tapson,VictorF;Weg,JohnG
• 通讯作者: Weg,JohnG