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Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)



Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)

For Condition: Lung Diseases,Venous Thromboembolism,Pulmonary Embolism
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To determine the value of contrast enhanced spiral computed tomography (spiral CT) for the diagnosis of acute pulmonary embolism (PE).
Details: 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:
Study Type:
  Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: > 18% normal kidney function, no dye allergies, suspected of acute pulmonary embolism
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
SarahFowler,  ,  George Washington University

Washington University *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Audrea  Lamb 314-747-4633

Weill Medical College of Cornell University *Recruiting*
New York City,  New York,  10021
United States
Recruiting Ame  Ng 212-746-2194

Duke University *Recruiting*
Durham,  North Carolina,  27710
United States
Recruiting Cheryl  Yetsko 919-668-2642

University of Calgary *Recruiting*
Calgary,  Alberta,  T2N 2T9
Canada
Recruiting Lance  Hoddinott (403) 670-8054

University of Michigan at Ann Arbor *Recruiting*
Ann Arbor,  Michigan,  48109-0360
United States
Recruiting Linda  Sawyer 734-936-7093

Case Western Reserve Univ-Henry Ford HSC *Recruiting*
Detroit,  Michigan,  48202
United States
Recruiting Lisa  Willcock 313-916-7057

Emory University *Recruiting*
Atlanta,  Georgia,  30308
United States
Recruiting Patricia  Dean 404-686-1368

Massachusetts General Hospital *Recruiting*
Boston,  Massachusetts,  02114
United States
Recruiting Jennifer  Ellis 617-724-9106


Additional Information:
Study ID Numbers:
  132; 
Study Start Date: September 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007085

Other Pulmonary Embolism Studies:
1. Oral Anticoagulant Therapy for Venous Thrombosis - SCOR in Thrombosis

2. Inflammation, Infection, and Future Cardiovascular Risk

3. Extended Prophylaxis for Venous Thromboembolism (VTE) in Acutely Ill Medical Patients with Prolonged Immobilization (EXCLAIM)

4. Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)

5. Prevention of Recurrent Venous Thromboembolism (PREVENT)

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