Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000566
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
1999-10-27
Brief Title:
Prospective Investigation of Pulmonary Embolism Diagnosis PIOPED
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2002-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
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