? ? The Prospective Investigation of Pulmonary Embolism Diagnosis in (PIOPED ffl) is a multicenter prospective investigation designed to give a quantitative assessment of the sensitivity and specificity of gadolinium enhanced magnetic resonance angiography (MRA) for the diagnosis of acute pulmonary embolism (PE). 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 central reading 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. This includes a validated clinical assessment, D-dimer by rapid enzyme-linked immunosorbent assay (ELIS A), compression ultrasound of the lower extremities, ventilation/perfusion (V/Q) lung scan, contrast enhanced spiral computed tomography (CT), and ultimately may include pulmonary digital subtraction angiography (DSA). It is expected that 317 patients will have PE and they will undergo gadolinium enhanced MRA. It is expected that 939 patients will be shown to have no PE. From among this group with no PE, 317 patients will be randomized for MRA (and venous ultrasound as well). All MRA images and all images used for the diagnosis or exclusion of PE in patients who had an MRA will be sent for blinded central readings by two readers. ? ?

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL077154-03
Application #
7254868
Study Section
Special Emphasis Panel (ZHL1-CSR-C (M3))
Program Officer
Reynolds, Herbert Y
Project Start
2005-08-01
Project End
2009-05-31
Budget Start
2007-09-16
Budget End
2008-05-31
Support Year
3
Fiscal Year
2007
Total Cost
$166,554
Indirect Cost
Name
Washington University
Department
Radiation-Diagnostic/Oncology
Type
Schools of Medicine
DUNS #
068552207
City
Saint Louis
State
MO
Country
United States
Zip Code
63130
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; Sostman, H Dirk; Hull, Russell D et al. (2009) Diagnosis of pulmonary embolism in the coronary care unit. Am J Cardiol 103:881-6
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