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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
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Diseases

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 7, 2000
    Last Updated
    July 28, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    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.
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    Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)

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