? ? The Biostatistics Center of George Washington University will participate as the Data Coordinating Center (DCC) for the """"""""Prospective Investigation Pulmonary Embolism Diagnosis Pulmonary III (PIOPED III)"""""""", which will assess the diagnostic validity of magnetic resonance angiography (MRA). This proposal is a companion application to that submitted by Paul Stein, MD, study chair, and 7 clinical investigators. The DCC Principal Investigator, Sarah Fowler, PhD, specializes in the design, conduct and coordination of multi-center studies, and has extensive experience in studies involving imaging. She will work closely with the collaborative group to assure the timely conduct of the study, coordinate and track the image reading, oversee data quality assurance, maintain a central database of study data, and collaborate with the other investigators on the statistical analysis and publication of study results. ? ? Working committees of the investigators will conduct reading and interpretation of images so that no investigator reviews images from his own center, and two independent readings (with adjudication if necessary) will be done for each image. The DCC will be responsible for designing and implementing the study's image transfer system. The DCC will provide a web-based image tracking system through which the DCC and image readers will track the exchange of images from the originating clinical center, through the DCC, to the blinded """"""""central"""""""" readers, and back to the DCC for archiving. Central readers will be blind to the patient's clinical assessment, and the results of all imaging studies except the one for their reading. ? ? The study will evaluate MRA in the broadest possible group of patients with suspected PE. Reading agreement and adjudication criteria and quality control procedures have been established. ? ?

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL077155-04
Application #
7499661
Study Section
Special Emphasis Panel (ZHL1-CSR-C (M3))
Program Officer
Moore, Timothy M
Project Start
2005-08-05
Project End
2010-08-31
Budget Start
2008-06-01
Budget End
2010-08-31
Support Year
4
Fiscal Year
2008
Total Cost
$856,105
Indirect Cost
Name
George Washington University
Department
Biostatistics & Other Math Sci
Type
Schools of Arts and Sciences
DUNS #
043990498
City
Washington
State
DC
Country
United States
Zip Code
20052
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
Londy, Frank Joseph; Lowe, Suzan; Stein, Paul D et al. (2012) Comparison of 1.5 and 3.0 T for contrast-enhanced pulmonary magnetic resonance angiography. Clin Appl Thromb Hemost 18:134-9
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