Prospective Investigation of Pulmonary Embolism Diagnosis III
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|ClinicalTrials.gov Identifier: NCT00241826|
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : August 20, 2013
|Condition or disease||Intervention/treatment|
|Lung Diseases Pulmonary Embolism||Procedure: Magnetic Resonance Angiography Procedure: Magnetic Resonance Venography|
Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III) follows PIOPED I and PIOPED II. PIOPED I was a multicenter trial supported between 1983 and 1989 to evaluate the sensitivity and specificity of two major, widely used technologies, radionuclear imaging (ventilation-perfusion scanning) and pulmonary angiography, for the diagnosis of PE. PIOPED II was a multicenter trial conducted between 2000 and 2005 to determine the value of contrast-enhanced spiral computed tomography (spiral CT) for the diagnosis of acute PE.
In PIOPED II, among 7,284 patients with suspected acute PE, 18.6% had an elevated creatinine, 3.9% were allergic to iodinated contrast material, and 4.7% of women were pregnant. One or more of these relative contraindications to an imaging procedure that would expose the patient to ionizing radiation or iodinated contrast material was present in 24.4% of patients with suspected acute PE. Although patients with relative contraindications often take the risk of CT or digital subtraction angiography (DSA) because of the importance of having a definitive diagnosis, such patients could benefit from safer diagnostic testing with Gd-MRA/MRV if it is shown to be sufficiently accurate.
The purpose of this investigation is to determine the extent to which Gd-MRA/MRV can serve as a diagnostic test in patients with clinically suspected PE and thereby eliminate the need for iodinated contrast material or ionizing radiation in patients who have a relative contraindication to one of them. This is important because 24% of patients with suspected acute PE have a relative contraindication to diagnostic procedures that involve ionizing radiation or iodinated contrast material.
PIOPED III is a multicenter prospective investigation designed to determine the diagnostic accuracy of Gd-MRA of the pulmonary arteries in combination with MRV of the veins of the thighs in patients with clinically suspected acute PE. The diagnostic accuracy of Gd-MRA alone and in combination with MRV will be expressed as sensitivity, specificity, and likelihood ratio for positive and negative tests. The study design is a prospective study of consecutive patients incorporating standardized inclusion/exclusion criteria, complete ascertainment of patient characteristics and outcomes, uniform diagnostic criteria, and unbiased paired central readings of imaging studies. Over a period of 2 years, 1,256 patients with suspected acute PE will be recruited at clinical centers. Composite reference standards will be used to diagnose venous thromboembolism (VTE) and exclude PE. It is expected that 314 patients will have acute VTE and they will undergo Gd-MRA/MRV. It is expected that 942 patients will be shown not to have PE. From among this group, 314 patients will be randomly selected for the index test, Gd-MRA/MRV.
|Study Type :||Observational|
|Estimated Enrollment :||1256 participants|
|Official Title:||Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III)|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||September 2008|
|Study Completion Date :||April 2009|
- Procedure: Magnetic Resonance Angiography
Participants will undergo magnetic resonance angiography.
- Procedure: Magnetic Resonance Venography
Participants will undergo magnetic resonance venography.
- Diagnosis or exclusion of pulmonary embolism in agreement with a reference standard [ Time Frame: Measured within 36 to 48 hours of study entry ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241826
|United States, Georgia|
|Atlanta, Georgia, United States, 30308|
|United States, Maryland|
|Divison of Lung Diseases, NHLBI|
|Bethesda, Maryland, United States, 20892|
|Data Coordinating Center|
|Rockville, Maryland, United States, 20852|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|University of Michigan Medical Center|
|Ann Arbor, Michigan, United States, 48109|
|St. Joseph Mercy-Oakland|
|Pontiac, Michigan, United States, 48341|
|United States, Missouri|
|Washington University Medical Center|
|St. Louis, Missouri, United States, 63110|
|United States, New York|
|NYU Medical Center|
|New York, New York, United States, 10016|
|Calgary, Alberta, Canada, T2N 2T9|
|Principal Investigator:||Sarah Fowler, PhD||George Washington University|
|Principal Investigator:||Charles Hales, MD||Massachusetts General Hospital|
|Principal Investigator:||Russell Hull, MBBS, MSc||University of Calgary|
|Principal Investigator:||Kenneth Leeper, Jr., MD||Emory University|
|Principal Investigator:||David Naidich, MD||NYU Langone Health|
|Principal Investigator:||Daniel Sak, Do||St. Joseph Mercy Oakland|
|Study Chair:||Paul D. Stein, MD||St. Joseph Mercy Oakland|
|Principal Investigator:||John Weg, MD||University of Michigan at Ann Arbor|
|Principal Investigator:||Pamela Woodard, MD||Washington University School of Medicine|