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Detection of Pulmonary Embolism With CECT
This study has been completed.
Sponsored by: Bracco Diagnostics, Inc
Information provided by: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT00351754
  Purpose

To compare the vascular enhancement of the two contrast agents in pulmonary Multi-detector CTA


Condition Intervention Phase
Pulmonary Embolism
Drug: Isovue
Phase IV

MedlinePlus related topics: Pulmonary Embolism
Drug Information available for: Iodixanol Iopamidol
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Detection of Pulmonary Embolism Comparing Isovue-370 and Visipaque 320 Using 64-Slice Multi-Detector Computed Tomographic Angiography

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Hounsfield Units (HU) measured at various levels of pulmonary arteries

Secondary Outcome Measures:
  • Presence of artifacts; global enhancement

Estimated Enrollment: 120
Study Start Date: July 2006
Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351754

Locations
United States, New Jersey
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Steve Sireci, M.D. Bracco Diagnostics
  More Information

Study ID Numbers: IOP 106
Study First Received: June 30, 2006
Last Updated: January 3, 2008
ClinicalTrials.gov Identifier: NCT00351754  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism
Lung Diseases
Vascular Diseases
Thrombosis

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009