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Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00007085
First Posted: December 8, 2000
Last Update Posted: July 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To determine the value of contrast enhanced spiral computed tomography (spiral CT) for the diagnosis of acute pulmonary embolism (PE).

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

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 2000
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
> 18% normal kidney function, no dye allergies, suspected of acute pulmonary embolism
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007085


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Sarah Fowler George Washington University
OverallOfficial: Charles Hales Massachusetts General Hospital
OverallOfficial: Russell Hull University of Calgary
OverallOfficial: Kenneth Leeper Emory University
OverallOfficial: John Popovich Case Western Reserve Univ-Henry Ford HSC
OverallOfficial: Henry Sostman Weill Medical College of Cornell University
OverallOfficial: Paul Stein St. Joseph Mercy
OverallOfficial: Victor Tapson Duke University
OverallOfficial: John Weg University of Michigan at Ann Arbor
OverallOfficial: Pamela Woodard Washington University School of Medicine
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00007085     History of Changes
Other Study ID Numbers: 132
U01HL063942 ( U.S. NIH Grant/Contract )
First Submitted: December 7, 2000
First Posted: December 8, 2000
Last Update Posted: July 29, 2016
Last Verified: January 2008

Additional relevant MeSH terms:
Lung Diseases
Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases