Prospective Investigation of Pulmonary Embolism Diagnosis III

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT00241826
First received: October 17, 2005
Last updated: August 19, 2013
Last verified: July 2009
  Purpose

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
Lung Diseases
Pulmonary Embolism
Procedure: Magnetic Resonance Angiography
Procedure: Magnetic Resonance Venography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III)

Resource links provided by NLM:


Further study details as provided by George Washington University:

Primary Outcome Measures:
  • Diagnosis or exclusion of pulmonary embolism in agreement with a reference standard [ Time Frame: Measured within 36 to 48 hours of study entry ] [ Designated as safety issue: No ]

Estimated Enrollment: 1256
Study Start Date: April 2006
Estimated Study Completion Date: April 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Magnetic Resonance Angiography
    Participants will undergo magnetic resonance angiography.
    Procedure: Magnetic Resonance Venography
    Participants will undergo magnetic resonance venography.
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People with suspected acute pulmonary embolism will be recruited for this study.

Criteria

Inclusion Criteria:

  • Acute PE of diagnostic concern
  • Informed consent
  • Willing to undergo Gd-MRA/MRV

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241826

Locations
United States, Georgia
Emory University
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
Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
George Washington University
Investigators
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 Early Recognition Center
  More Information

No publications provided by George Washington University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT00241826     History of Changes
Other Study ID Numbers: 329, U01HL077155, 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 19, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Embolism
Lung Diseases
Pulmonary Embolism
Cardiovascular Diseases
Embolism and Thrombosis
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014