Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00007085
First received: December 7, 2000
Last updated: January 18, 2008
Last verified: January 2008
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007085

Sponsors and Collaborators
Investigators
Investigator: Sarah Fowler George Washington University
Investigator: Charles Hales Massachusetts General Hospital
Investigator: Russell Hull University of Calgary
Investigator: Kenneth Leeper Emory University
Investigator: John Popovich Case Western Reserve Univ-Henry Ford HSC
Investigator: Henry Sostman Weill Medical College of Cornell University
Investigator: Paul Stein St. Joseph Mercy
Investigator: Victor Tapson Duke University
Investigator: John Weg University of Michigan at Ann Arbor
Investigator: Pamela Woodard Washington University Early Recognition Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00007085     History of Changes
Other Study ID Numbers: 132
Study First Received: December 7, 2000
Last Updated: January 18, 2008
Health Authority: Unspecified

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

ClinicalTrials.gov processed this record on August 20, 2014