Prospective Investigation of Pulmonary Embolism Diagnosis III

Pulmonary Embolism Clinical Trial

Official title:

Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241826
• Other study ID #: 329
• Secondary ID: U01HL077155U01HL
• Status: Completed
• Phase: N/A
• First received: October 17, 2005
• Last updated: August 19, 2013
• Start date: April 2006
• Est. completion date: April 2009

Study information

• Verified date: July 2009
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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 venography (MRV) of the veins of the thighs in patients with clinically suspected acute pulmonary embolism (PE).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1256
• Est. completion date: April 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Embolism
• Lung Diseases
• Pulmonary Embolism

Intervention

Procedure:
• Magnetic Resonance Angiography
Participants will undergo magnetic resonance angiography.
• Magnetic Resonance Venography
Participants will undergo magnetic resonance venography.

Locations

Country	Name	City	State
Canada	Foothills Hospital	Calgary	Alberta
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Divison of Lung Diseases, NHLBI	Bethesda	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	NYU Medical Center	New York	New York
United States	St. Joseph Mercy-Oakland	Pontiac	Michigan
United States	Data Coordinating Center	Rockville	Maryland
United States	Washington University Medical Center	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
George Washington University	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis or exclusion of pulmonary embolism in agreement with a reference standard		Measured within 36 to 48 hours of study entry	No