Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)

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

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Venous Thromboembolism; Pulmonary Embolism
• Intervention / Treatment: Device: Tomography, X-ray Computed

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).

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: December 7, 2000
• First Submitted That Met QC Criteria: December 7, 2000
• First Posted (Estimate): December 8, 2000

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Lung Diseases; Embolism; Thromboembolism; Venous Thromboembolism; Pulmonary Embolism
• Other Study ID Numbers: 132; U01HL063942 (U.S. NIH Grant/Contract)