Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED)

April 14, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To evaluate the sensitivity and specificity of two major, widely used technologies, radionuclear imaging (ventilation-perfusion scanning) and pulmonary angiography, for the diagnosis of pulmonary embolism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

In 1983, reliable data on the incidence of pulmonary embolism in the adult population and in groups identified at risk were not available because the sensitivity and specificity of the diagnostic procedures had not been determined. Estimates suggested there were about half a million episodes of pulmonary embolism in hospitalized patients each year in the United States. Deaths attributable to pulmonary embolism would be expected in about one third of these patients if left untreated.

The clinical diagnosis of pulmonary embolism was subject to a high frequency of false positives and false negatives. The most definitive diagnostic procedure was pulmonary angiography, an invasive, expensive procedure which was not without risk. It required specialized equipment and highly trained personnel both for performance and for interpretation. Therefore, it was used to diagnose pulmonary embolism only in the major medical centers. Another technique utilized as a method to diagnose pulmonary embolism involved a combination of perfusion and ventilation scanning; this method was only minimally invasive. A normal perfusion scan was thought to be of considerable value because it essentially excluded the diagnosis of pulmonary embolism. In selected patient populations, abnormal perfusion scans combined with normal ventilation scans were of substantial help in diagnosis.

Although there had been no acceptable validation of the use of perfusion scans in the diagnosis of pulmonary embolism, thousands of patients had been evaluated for pulmonary embolism based on perfusion scanning often using methods of imaging now considered to be inadequate. In the early 1980s, clinical practice interpreted a negative perfusion scan as overwhelming evidence against the presence of pulmonary emboli. This interpretation had not been adequately tested either in a prospective study or by long-term follow-up of patients to determine clinical outcome. With regards to positive perfusion scans, there were data to suggest that as many as two-thirds of positive perfusion scans could not subsequently be confirmed by pulmonary angiography. Prospective studies in which timely angiograms using selective injections and improved imaging techniques were needed to evaluate the usefulness of positive perfusion scans.

Phase I was initiated in September 1983. Protocols developed during Phase I underwent independent assessment review in April 1984 and were reviewed and approved by the May 1984 National Heart, Lung, and Blood Advisory Council. Recruitment and intervention started in January 1985 and ended in September 1986. Follow-up was completed on September 30, 1987.

DESIGN NARRATIVE:

Patients suspected of pulmonary embolism underwent a ventilation-perfusion scan. Patients with an abnormal perfusion scan underwent angiography. All patients were followed for one year.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Men and women suspected of having a pulmonary embolism and who met the criteria to undergo angiography.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Abass Alavi, University of Pennsylvania
  • Richard Greenspan, Yale University
  • Charles Hales, Massachusetts General Hospital
  • Herbert Saltzman, Duke University
  • Paul Stein, Henry Ford Hospital
  • John Weg, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1983

Study Completion

December 1, 1989

Study Registration Dates

First Submitted

October 27, 1999

First Submitted That Met QC Criteria

October 27, 1999

First Posted (Estimate)

October 28, 1999

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

June 1, 2002

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 204 (Fakultät für Psychologie Ethikkommission, Ruhr University of Bochum)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: PIOPED
    Information comments: NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
  2. Study Protocol
  3. Study Forms

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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