Status:
COMPLETED
Prospective Investigation of Pulmonary Embolism Diagnosis III
Lead Sponsor:
George Washington University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Lung Diseases
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Brief Summary
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 venogr...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Acute PE of diagnostic concern
- Informed consent
- Willing to undergo Gd-MRA/MRV
Exclusion
- Any implanted ferromagnetic foreign body, including a ferromagnetic cerebral aneurysm clip or implanted electrical device/pump
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
1256 Patients enrolled
Trial Details
Trial ID
NCT00241826
Start Date
April 1 2006
End Date
April 1 2009
Last Update
August 20 2013
Active Locations (9)
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1
Emory University
Atlanta, Georgia, United States, 30308
2
Divison of Lung Diseases, NHLBI
Bethesda, Maryland, United States, 20892
3
Data Coordinating Center
Rockville, Maryland, United States, 20852
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114