Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00007085
First received: December 7, 2000
Last updated: January 18, 2008
Last verified: January 2008

December 7, 2000
January 18, 2008
September 2000
December 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00007085 on ClinicalTrials.gov Archive Site
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Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)
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To determine the value of contrast enhanced spiral computed tomography (spiral CT) for the diagnosis of acute pulmonary embolism (PE).

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).

Interventional
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Primary Purpose: Diagnostic
  • Lung Diseases
  • Pulmonary Embolism
  • Venous Thromboembolism
Device: Tomography, X-ray Computed
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2004
December 2004   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00007085
132
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Sarah Fowler George Washington University
Investigator: Charles Hales Massachusetts General Hospital
Investigator: Russell Hull University of Calgary
Investigator: Kenneth Leeper Emory University
Investigator: John Popovich Case Western Reserve Univ-Henry Ford HSC
Investigator: Henry Sostman Weill Medical College of Cornell University
Investigator: Paul Stein St. Joseph Mercy
Investigator: Victor Tapson Duke University
Investigator: John Weg University of Michigan at Ann Arbor
Investigator: Pamela Woodard Washington University Early Recognition Center
National Heart, Lung, and Blood Institute (NHLBI)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP