This is a multicenter collaborative study to determine the sensitivity, specificity, positive and negative predictive value of contrast enhanced spiral computed tomography (spiral CT) for the diagnosis of acute pulmonary embolism (PE). Pulmonary embolism is common, yet frequently undiagnosed and fatal. Spiral CT is a nearly noninvasive test that offers the possibility of a definitive diagnosis of PE by showing the outline of the thrombus in a pulmonary artery. However, its utility in the diagnosis of PE is unknown. Even though spiral CT has not been adequately validated, physicians at many hospitals now use it as a definitive and only diagnostic test. This could lead to overtreatment or undertreatment, both of which have serious potential complications. The role of spiral CT in the diagnosis of PE requires an accurate evaluation which will be made in this investigation by a composite of diagnostic tests including pulmonary angiography, ventilation/perfusion lung scans, venous compression ultrasound and outcome analysis. The strengths of this proposal are: 1) the importance of the problem of PE in terms of lives lost from underdiagnosis, and major bleeding from overdiagnosis, and 2) the potential applicability of a new technology for the diagnosis of PE that will have widespread availability. 3) The protocol parallels standard diagnostic strategy, without subjecting the patients to risk entirely for the acquisition of data. 4) The team of investigators is strong, and has collaborated previously in successful research in PE.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL067453-02
Application #
6390997
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Vreim, Carol
Project Start
2000-09-10
Project End
2004-07-31
Budget Start
2001-08-20
Budget End
2002-07-31
Support Year
2
Fiscal Year
2001
Total Cost
$416,958
Indirect Cost
Name
St. Joseph Mercy Oakland
Department
Type
DUNS #
807924803
City
Pontiac
State
MI
Country
United States
Zip Code
48341
Stein, Paul D; Matta, Fadi; Yaekoub, Abdo Y et al. (2009) Reconstructed 4-chamber views compared with axial imaging for assessment of right ventricular enlargement on CT pulmonary angiograms. J Thromb Thrombolysis 28:342-7
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
Sostman, H Dirk; Miniati, Massimo; Gottschalk, Alexander et al. (2008) Sensitivity and specificity of perfusion scintigraphy combined with chest radiography for acute pulmonary embolism in PIOPED II. J Nucl Med 49:1741-8
Stein, Paul D; Beemath, Afzal; Matta, Fadi et al. (2008) Enlarged right ventricle without shock in acute pulmonary embolism: prognosis. Am J Med 121:34-42
Sostman, H Dirk; Stein, Paul D; Gottschalk, Alexander et al. (2008) Acute pulmonary embolism: sensitivity and specificity of ventilation-perfusion scintigraphy in PIOPED II study. Radiology 246:941-6
Goodman, Lawrence R; Stein, Paul D; Matta, Fadi et al. (2007) CT venography and compression sonography are diagnostically equivalent: data from PIOPED II. AJR Am J Roentgenol 189:1071-6
Gottschalk, Alexander; Stein, Paul D; Sostman, H Dirk et al. (2007) Very low probability interpretation of V/Q lung scans in combination with low probability objective clinical assessment reliably excludes pulmonary embolism: data from PIOPED II. J Nucl Med 48:1411-5
Stein, Paul D; Woodard, Pamela K; Weg, John G et al. (2007) Diagnostic pathways in acute pulmonary embolism: recommendations of the PIOPED II Investigators. Radiology 242:15-21
Stein, Paul D; Beemath, Afzal; Quinn, Deborah A et al. (2007) Usefulness of multidetector spiral computed tomography according to age and gender for diagnosis of acute pulmonary embolism. Am J Cardiol 99:1303-5
Stein, Paul D; Beemath, Afzal; Matta, Fadi et al. (2007) Clinical characteristics of patients with acute pulmonary embolism: data from PIOPED II. Am J Med 120:871-9

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