This is a multicenter collaborative study to determine the sensitivity, specificity, positive predictive value, and negative predictive value of contrast enhanced spiral computed tomography (spiral CT) for the diagnosis of acute pulmonary embolism (PE). PE 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 proven PE. Pulmonary angiography is the currently definitive diagnostic test, but there is hesitancy to use it because of morbidity, discomfort, cost, and lack of availability in community hospitals. Contrast enhanced spiral CT is a nearly noninvasive test that offers the possibility of a definitive diagnosis of PE by showing the outline of the embolus 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 for PE, or as a definitive test in patients in whom the ventilation/perfusion lung scan is nondiagnostic. 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 through the use of pulmonary angiography, the ventilation/perfusion scan, and compression ultrasound of the legs. Venous ultrasonography has been incorporated into this protocol because it permits a strategy of management based on venous thromboembolic disease (PE or deep venous thrombosis) in some patients. 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 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 and 4) the team of investigators is strong and experienced.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL063932-02
Application #
6402775
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Vreim, Carol
Project Start
2000-09-01
Project End
2004-07-31
Budget Start
2001-08-10
Budget End
2002-07-31
Support Year
2
Fiscal Year
2001
Total Cost
$340,160
Indirect Cost
Name
Duke University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
071723621
City
Durham
State
NC
Country
United States
Zip Code
27705
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. (2007) Clinical characteristics of patients with acute pulmonary embolism: data from PIOPED II. Am J Med 120:871-9
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; 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