This is a multicenter collaborative study to determine the sensitivity, specificity and predictive values 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. Ventilation/ perfusion lung scans are the most commonly used test. However, they are nondiagnostic in 72 percent of patients with suspected PE and in 57 percent of patients with subsequently proven PE. Pulmonary angiography is the definitive diagnostic test in such patients, but there is hesitancy to use it because of morbidity, discomfort, cost, and lack of availability is community hospitals. Noninvasive leg tests, particularly venous ultrasound, permit a strategy of management by treatment on the basis of venous thromboembolic disease (PE or DVT). 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 not established. Even though spiral CT has not been adequately validated, many hospitals now use it as a first diagnostic test for PE, or as a definitive test in patients in whom the ventilation/perfusion lung scan is nondiagnostic. This could lead to over- or undertreatment, which have serious potential complications. In view of the potential applicability of spiral CT, this investigation is proposed to test its sensitivity, specificity, positive and negative predictive values, using contemporary diagnostic reference standard methods. The strengths of this proposal are: 1) the importance of the problem of PE diagnosis, 2) the potential of a widely available technology for the diagnosis, 3) a protocol that parallels standard diagnostic strategy without subjecting patients to risk only for data acquisition, 4) a strong team of investigators, which 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 #
5U01HL063981-02
Application #
6402784
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Vreim, Carol
Project Start
2000-09-01
Project End
2004-07-31
Budget Start
2001-08-01
Budget End
2002-07-31
Support Year
2
Fiscal Year
2001
Total Cost
$408,230
Indirect Cost
Name
Weill Medical College of Cornell University
Department
Radiation-Diagnostic/Oncology
Type
Schools of Medicine
DUNS #
201373169
City
New York
State
NY
Country
United States
Zip Code
10065
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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; 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
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; Woodard, Pamela K; Weg, John G et al. (2006) Diagnostic pathways in acute pulmonary embolism: recommendations of the PIOPED II investigators. Am J Med 119:1048-55
Stein, Paul D; Fowler, Sarah E; Goodman, Lawrence R et al. (2006) Multidetector computed tomography for acute pulmonary embolism. N Engl J Med 354:2317-27