To determine the value of contrast enhanced spiral computed tomography (spiral CT) for the diagnosis of acute pulmonary embolism (PE).

Condition	Treatment or Intervention
Lung Diseases Pulmonary Embolism Venous Thromboembolism	Device: Tomography, X-ray Computed

Further Study Details: 

BACKGROUND: Approximately 600,000 Americans sustain pulmonary embolism each year; one-third of these episodes are fatal. Unfortunately, pulmonary embolism is underdiagnosed and, therefore, under-treated. A substantial body of evidence suggests that the diagnosis of pulmonary embolism is not made in the majority of patients in whom it causes or contributes to death.

In the main, there are two explanations for the failure to diagnose pulmonary embolism: pulmonary embolism may be clinically silent, and there is no definitive, noninvasive diagnostic test. Indeed, ventilation perfusion lung scans are nondiagnostic in the majority of patients with suspected acute pulmonary embolism. Pulmonary angiography may be used to establish a diagnosis in such patients, but it is underutilized because of a mortality risk around 1 percent.

Recently, relatively small studies have suggested that contrast enhanced spiral computed tomography (CT) scanning is a useful diagnostic test for pulmonary embolism, with sensitivity as high as 80 percent and specificity as high as 95 percent. Spiral CT is widely available and much less invasive than pulmonary angiography. If spiral CT could be established as a useful diagnostic test, pulmonary embolism would be diagnosed more effectively and more patients would receive proper treatment.

DESIGN NARRATIVE: The study evaluates the role of spiral CT scan in the diagnosis of PE by comparison with a composite reference test, including pulmonary angiography, V/Q lung scan in patients without prior PE and compression ultrasound of the lower extremities in patients with no prior deep venous thrombosis (DVT).

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

> 18% normal kidney function, no dye allergies, suspected of acute pulmonary embolism

Study chairs or principal investigators

Sarah Fowler,  George Washington University   
Charles Hales,  Massachusetts General Hospital   
Russell Hull,  University of Calgary   
Kenneth Leeper,  Emory University   
John Popovich,  Case Western Reserve Univ-Henry Ford HSC   
Henry Sostman,  Cornell University Medical College   
Paul Stein,  St. Joseph Mercy   
Victor Tapson,  Duke University   
John Weg,  University of Michigan at Ann Arbor   
Pamela Woodard,  Washington University School of Medicine   

Study ID Numbers:  132
Record last reviewed:  October 2004
Last Updated:  October 14, 2004
Record first received:  December 7, 2000
ClinicalTrials.gov Identifier:  NCT00007085
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08