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Detection of Pulmonary Embolism With CECT

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ClinicalTrials.gov Identifier: NCT00351754
Recruitment Status : Completed
First Posted : July 13, 2006
Last Update Posted : January 7, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
To compare the vascular enhancement of the two contrast agents in pulmonary Multi-detector CTA

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Drug: Isovue Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Detection of Pulmonary Embolism Comparing Isovue-370 and Visipaque 320 Using 64-Slice Multi-Detector Computed Tomographic Angiography
Study Start Date : July 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Iopamidol
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. Presence of artifacts; global enhancement

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00351754     History of Changes
Other Study ID Numbers: IOP 106
First Posted: July 13, 2006    Key Record Dates
Last Update Posted: January 7, 2008
Last Verified: January 2008

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