Back to resultsDetection of Pulmonary Embolism With CECT
Primary Purpose
Pulmonary Embolism
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Isovue
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Embolism
Eligibility Criteria
Inclusion Criteria: Patients 18 yrs or older With suspected PE Referred for MDCTA of pulmonary arteries Signed informed consent Exclusion Criteria: Pregnant and lactating females History of hypersensitivity to iodinated contrast agents Hyperthyroidism or pheochromocytoma Severe CHF Renal impairment Weight greater than 300 lbs Pacemaker Swan Ganz catheter Defibrillator or other intrathoracic metallic vascular device Received an investigational compound within 30 days of being in the study
Sites / Locations
- Bracco Diagnostics, Inc.
Outcomes
Primary Outcome Measures
Hounsfield Units (HU) measured at various levels of pulmonary arteries
Secondary Outcome Measures
Presence of artifacts; global enhancement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00351754
Brief Title
Detection of Pulmonary Embolism With CECT
Official Title
Detection of Pulmonary Embolism Comparing Isovue-370 and Visipaque 320 Using 64-Slice Multi-Detector Computed Tomographic Angiography
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bracco Diagnostics, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the vascular enhancement of the two contrast agents in pulmonary Multi-detector CTA
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Isovue
Primary Outcome Measure Information:
Title
Hounsfield Units (HU) measured at various levels of pulmonary arteries
Secondary Outcome Measure Information:
Title
Presence of artifacts; global enhancement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 18 yrs or older
With suspected PE
Referred for MDCTA of pulmonary arteries
Signed informed consent
Exclusion Criteria:
Pregnant and lactating females
History of hypersensitivity to iodinated contrast agents
Hyperthyroidism or pheochromocytoma
Severe CHF
Renal impairment
Weight greater than 300 lbs
Pacemaker
Swan Ganz catheter
Defibrillator or other intrathoracic metallic vascular device
Received an investigational compound within 30 days of being in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Sireci, M.D.
Organizational Affiliation
Bracco Diagnostics
Official's Role
Study Director
Facility Information:
Facility Name
Bracco Diagnostics, Inc.
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Detection of Pulmonary Embolism With CECT
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