? ? 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. ? ?

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL081593-02
Application #
7104855
Study Section
Special Emphasis Panel (ZHL1-CSR-C (M3))
Program Officer
Denholm, Elizabeth M
Project Start
2005-08-01
Project End
2009-05-31
Budget Start
2006-06-01
Budget End
2007-09-15
Support Year
2
Fiscal Year
2006
Total Cost
$593,597
Indirect Cost
Name
New York University
Department
Radiation-Diagnostic/Oncology
Type
Schools of Medicine
DUNS #
121911077
City
New York
State
NY
Country
United States
Zip Code
10016
Woodard, Pamela K; Chenevert, Thomas L; Sostman, H Dirk et al. (2012) Signal quality of single dose gadobenate dimeglumine pulmonary MRA examinations exceeds quality of MRA performed with double dose gadopentetate dimeglumine. Int J Cardiovasc Imaging 28:295-301
Sostman, H Dirk; Jablonski, Kathleen A; Woodard, Pamela K et al. (2012) Factors in the technical quality of gadolinium enhanced magnetic resonance angiography for pulmonary embolism in PIOPED III. Int J Cardiovasc Imaging 28:303-12
Stein, Paul D; Chenevert, Thomas L; Fowler, Sarah E et al. (2010) Gadolinium-enhanced magnetic resonance angiography for pulmonary embolism: a multicenter prospective study (PIOPED III). Ann Intern Med 152:434-43, W142-3
Stein, Paul D; Gottschalk, Alexander; Sostman, H Dirk et al. (2008) Methods of Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III). Semin Nucl Med 38:462-70