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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00241826 |
The purpose of this study is to determine the diagnostic accuracy of gadolinium-enhanced magnetic resonance angiography (Gd-MRA) of the pulmonary arteries in combination with magnetic resonance venography (MRV) of the veins of the thighs in patients with clinically suspected acute pulmonary embolism (PE).
Condition | Intervention |
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Lung Diseases Pulmonary Embolism |
Procedure: Magnetic Resonance Angiography Procedure: Magnetic Resonance Venography |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III) |
Estimated Enrollment: | 1256 |
Study Start Date: | April 2006 |
BACKGROUND:
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.
DESIGN NARRATIVE:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
People with suspected acute pulmonary embolism will be recruited for this study.
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul D. Stein, MD | 248-858-6772 | steinp@trinity-health.org |
United States, Georgia | |
Emory University | Recruiting |
Atlanta, Georgia, United States, 30308 | |
Contact: Kenneth Leeper, Jr., MD 404-686-1364 ken_leeper@emoryhealthcare.org | |
United States, Maryland | |
Data Coordinating Center | Recruiting |
Rockville, Maryland, United States, 20852 | |
Contact: Sarah Fowler, PhD 301-881-9260 fowler@biostat.bsc,gwu.edu | |
Divison of Lung Diseases, NHLBI | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: Elizabeth Denholm, PhD 301-435-0222 denholme@nhlbi.nih.gov | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Charles Hales, MD 617-726-8854 chales@partners.org | |
United States, Michigan | |
St. Joseph Mercy-Oakland | Recruiting |
Pontiac, Michigan, United States, 48341 | |
Contact: Daniel Sak, DO 248-371-1726 ext 7 SAKDJ@trinity-health.org | |
University of Michigan Medical Center | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: John Weg, MD 734-936-5245 jweg@umich.edu | |
United States, Missouri | |
Washington University Medical Center | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Pamela Woodard, MD 314-362-9989 woodardp@mir.wustl.edu | |
United States, New York | |
NYU Medical Center | Recruiting |
New York, New York, United States, 10016 | |
Contact: David Naidich, MD 212-263-5229 david.naidich@nyumc.org | |
Canada, Alberta | |
Foothills Hospital | Recruiting |
Calgary, Alberta, Canada, T2N 2T9 | |
Contact: Russell Hull, MBBS, MSc 403-944-8047 Jeanne.Sheldon@calgaryhealthregion.ca |
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 | New York University School of Medicine |
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 |
Responsible Party: | St. Joseph Mercy Oakland ( Paul D. Stein, MD ) |
Study ID Numbers: | 329, U01 HL77149, U01 HL77150, U01 HL77151, U01 HL77153, U01 HL77154, U01 HL77155, U01 HL77358, U01 HL81593, U01 HL81594 |
Study First Received: | October 17, 2005 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00241826 History of Changes |
Health Authority: | United States: Federal Government |
Embolism and Thrombosis Pulmonary Embolism Respiratory Tract Diseases Embolism |
Lung Diseases Vascular Diseases Thrombosis |
Embolism and Thrombosis Pulmonary Embolism Respiratory Tract Diseases Embolism |
Lung Diseases Vascular Diseases Cardiovascular Diseases |