Detection of Pulmonary Embolism With CECT

• Sponsor: Bracco Diagnostics, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00351754
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Duration (Months): 4
• Patients Per Site Per Month: 29.7

Study Details

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
• 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: Jul 1, 2006
• Actual Study Completion Date: Nov 1, 2006

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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Bracco Diagnostics, Inc.	Princeton	New Jersey	United States	08540

Sponsors and Collaborators

• Bracco Diagnostics, Inc

Investigators

• Study Director: Steve Sireci, M.D., Bracco Diagnostics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00351754
• Other Study ID Numbers: IOP 106
• First Posted: Jul 13, 2006
• Last Update Posted: Jan 7, 2008
• Last Verified: Jan 1, 2008

• Additional relevant MeSH terms: Pulmonary Embolism; Embolism

Study Results

No Results Posted as of Jan 7, 2008