Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)
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| First Received Date ICMJE | December 7, 2000 | ||||||||||||||||||||||||||||||||||||||||
| Last Updated Date | January 18, 2008 | ||||||||||||||||||||||||||||||||||||||||
| Start Date ICMJE | September 2000 | ||||||||||||||||||||||||||||||||||||||||
| Primary Completion Date | December 2004 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00007085 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||||||||||||||||||
| Brief Title ICMJE | Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II) | ||||||||||||||||||||||||||||||||||||||||
| Official Title ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||||||
| Brief Summary | To determine the value of contrast enhanced spiral computed tomography (spiral CT) for the diagnosis of acute pulmonary embolism (PE). |
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| 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). |
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| Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||||||||||||||||||||||||||
| Study Design ICMJE | Primary Purpose: Diagnostic | ||||||||||||||||||||||||||||||||||||||||
| Condition ICMJE |
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| Intervention ICMJE | Device: Tomography, X-ray Computed | ||||||||||||||||||||||||||||||||||||||||
| Study Arm (s) | Not Provided | ||||||||||||||||||||||||||||||||||||||||
| Publications * | 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. | ||||||||||||||||||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||||||||||||||||||
| Enrollment ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||||||
| Completion Date | December 2004 | ||||||||||||||||||||||||||||||||||||||||
| Primary Completion Date | December 2004 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | > 18% normal kidney function, no dye allergies, suspected of acute pulmonary embolism |
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| Gender | Both | ||||||||||||||||||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||||||||||
| Location Countries ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT00007085 | ||||||||||||||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 132 | ||||||||||||||||||||||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||||||||||||||||||||||
| Responsible Party | Not Provided | ||||||||||||||||||||||||||||||||||||||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||||||||||||||||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||||||||||||||||||||||||||||||||||
| Verification Date | January 2008 | ||||||||||||||||||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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