Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)
Primary Purpose
Lung Diseases, Pulmonary Embolism, Venous Thromboembolism
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tomography, X-ray Computed
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Diseases
Eligibility Criteria
> 18% normal kidney function, no dye allergies, suspected of acute pulmonary embolism
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00007085
First Posted
December 7, 2000
Last Updated
July 28, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00007085
Brief Title
Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Pulmonary Embolism, Venous Thromboembolism
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Tomography, X-ray Computed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
> 18% normal kidney function, no dye allergies, suspected of acute pulmonary embolism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Fowler
Organizational Affiliation
George Washington University
First Name & Middle Initial & Last Name & Degree
Charles Hales
Organizational Affiliation
Massachusetts General Hospital
First Name & Middle Initial & Last Name & Degree
Russell Hull
Organizational Affiliation
University of Calgary
First Name & Middle Initial & Last Name & Degree
Kenneth Leeper
Organizational Affiliation
Emory University
First Name & Middle Initial & Last Name & Degree
John Popovich
Organizational Affiliation
Case Western Reserve Univ-Henry Ford HSC
First Name & Middle Initial & Last Name & Degree
Henry Sostman
Organizational Affiliation
Weill Medical College of Cornell University
First Name & Middle Initial & Last Name & Degree
Paul Stein
Organizational Affiliation
St. Joseph Mercy
First Name & Middle Initial & Last Name & Degree
Victor Tapson
Organizational Affiliation
Duke University
First Name & Middle Initial & Last Name & Degree
John Weg
Organizational Affiliation
University of Michigan at Ann Arbor
First Name & Middle Initial & Last Name & Degree
Pamela Woodard
Organizational Affiliation
Washington University School of Medicine
12. IPD Sharing Statement
Citations:
PubMed Identifier
12105798
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.
Results Reference
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Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)
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