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Detection of Pulmonary Embolism With CECT

This study has been completed.
Sponsor:
Information provided by:
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00351754
First received: June 30, 2006
Last updated: January 3, 2008
Last verified: January 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Pulmonary Embolism
 Drug: Isovue
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Detection of Pulmonary Embolism Comparing Isovue-370 and Visipaque 320 Using 64-Slice Multi-Detector Computed Tomographic Angiography

Resource links provided by NLM:

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

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

No publications provided

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

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

ClinicalTrials.gov processed this record on May 16, 2013