Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00007085
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2000-12-07
Brief Title:
Prospective Investigation of Pulmonary Embolism Diagnosis PIOPED II
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:
2008-01
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 determine the value of contrast enhanced spiral computed tomography spiral CT for the diagnosis of acute pulmonary embolism PE
Detailed Description:
BACKGROUND
Approximately 600000 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 VQ lung scan in patients without prior PE and compression ultrasound of the lower extremities in patients with no prior deep venous thrombosis DVT
Approximately 600000 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 VQ lung scan in patients without prior PE and compression ultrasound of the lower extremities in patients with no prior deep venous thrombosis DVT
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?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL063942 | NIH | None | httpsreporternihgovquickSearchU01HL063942 |