Prospective Investigation of Pulmonary Embolism Diagnosis III
NCT ID: NCT00241826
Last Updated: 2013-08-20
Study Results
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Basic Information
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COMPLETED
1256 participants
OBSERVATIONAL
2006-04-30
2009-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Magnetic Resonance Angiography
Participants will undergo magnetic resonance angiography.
Magnetic Resonance Venography
Participants will undergo magnetic resonance venography.
Eligibility Criteria
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Inclusion Criteria
* Informed consent
* Willing to undergo Gd-MRA/MRV
Exclusion Criteria
* Dependency on a continuous connection to an external electrical device/pump (e.g., pacemaker, internal defibrillator, cochlear implant, nerve or bone stimulator implant, ICU appliance) and cardiac pacing wires
* Severe claustrophobia
* Severe shaking
* Inability to lie still for 30 minutes
* Pregnancy and nursing mothers
* Serum creatinine levels within range of normal at local center
* Sickle cell anemia, other hemoglobinopathies, and other hemolytic anemias
* Critical illness, shock or hypotension, hemodynamic instability, ventilatory support, chronic anticoagulation, inferior vena cava filter
* Documented episodes of ventricular fibrillation or sustained ventricular tachycardia within the past 24 hours
* Myocardial infarction within the past month
* History of allergy to gadolinium-containing contrast agents or to iodinated contrast media
* Current symptomatic asthma
* Clinical evidence of venous thrombosis of the upper extremity
* Prisoners
* Institutionalized or mentally handicapped patients
* Too large to fit in MRI unit
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
George Washington University
OTHER
Responsible Party
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Principal Investigators
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Sarah Fowler, PhD
Role: PRINCIPAL_INVESTIGATOR
George Washington University
Charles Hales, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Russell Hull, MBBS, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Kenneth Leeper, Jr., MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
David Naidich, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Daniel Sak, Do
Role: PRINCIPAL_INVESTIGATOR
St. Joseph Mercy Oakland
Paul D. Stein, MD
Role: STUDY_CHAIR
St. Joseph Mercy Oakland
John Weg, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan at Ann Arbor
Pamela Woodard, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Emory University
Atlanta, Georgia, United States
Divison of Lung Diseases, NHLBI
Bethesda, Maryland, United States
Data Coordinating Center
Rockville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
St. Joseph Mercy-Oakland
Pontiac, Michigan, United States
Washington University Medical Center
St Louis, Missouri, United States
NYU Medical Center
New York, New York, United States
Foothills Hospital
Calgary, Alberta, Canada
Countries
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References
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Stein PD, Chenevert TL, Fowler SE, Goodman LR, Gottschalk A, Hales CA, Hull RD, Jablonski KA, Leeper KV Jr, Naidich DP, Sak DJ, Sostman HD, Tapson VF, Weg JG, Woodard PK; PIOPED III (Prospective Investigation of Pulmonary Embolism Diagnosis III) Investigators. Gadolinium-enhanced magnetic resonance angiography for pulmonary embolism: a multicenter prospective study (PIOPED III). Ann Intern Med. 2010 Apr 6;152(7):434-43, W142-3. doi: 10.7326/0003-4819-152-7-201004060-00008.
Other Identifiers
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329
Identifier Type: -
Identifier Source: org_study_id