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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014