Clinical trial NCT00007085: Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Pulmonary Embolism
Venous Thromboembolism
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-12-08
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

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

Detailed description: 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).

Eligibility criteria: \> 18% normal kidney function, no dye allergies, suspected of acute pulmonary embolism

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: George Washington University
name: Sarah Fowler
affiliation: Massachusetts General Hospital
name: Charles Hales
affiliation: University of Calgary
name: Russell Hull
affiliation: Emory University
name: Kenneth Leeper
affiliation: Case Western Reserve Univ-Henry Ford HSC
name: John Popovich
affiliation: Weill Medical College of Cornell University
name: Henry Sostman
affiliation: St. Joseph Mercy
name: Paul Stein
affiliation: Duke University
name: Victor Tapson
affiliation: University of Michigan at Ann Arbor
name: John Weg
affiliation: Washington University School of Medicine
name: Pamela Woodard
References:
citation: Gottschalk A, Stein PD, Goodman LR, Sostman HD. Overview of Prospective Investigation of Pulmonary Embolism Diagnosis II. Semin Nucl Med. 2002 Jul;32(3):173-82. doi: 10.1053/snuc.2002.124177.