Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)

NCT ID: NCT00007085

Last Updated: 2016-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2004-12-31

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).

Conditions

Lung Diseases; Pulmonary Embolism; Venous Thromboembolism

Study Design

• Primary Study Purpose: DIAGNOSTIC

Interventions

Tomography, X-ray Computed

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Principal Investigators

Sarah Fowler

Role:

George Washington University

Charles Hales

Role:

Massachusetts General Hospital

Russell Hull

Role:

University of Calgary

Kenneth Leeper

Role:

Emory University

John Popovich

Role:

Case Western Reserve Univ-Henry Ford HSC

Henry Sostman

Role:

Weill Medical College of Cornell University

Paul Stein

Role:

St. Joseph Mercy

Victor Tapson

Role:

Duke University

John Weg

Role:

University of Michigan at Ann Arbor

Pamela Woodard

Role:

Washington University School of Medicine

References

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.

Reference Type: BACKGROUND

PMID: 12105798 (View on PubMed)

Other Identifiers

U01HL063942

Identifier Type: NIH

Identifier Source: secondary_id

View Link

132

Identifier Type: -

Identifier Source: org_study_id