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NCT00351754 Clinical Trial

Detection of Pulmonary Embolism With CECT

Pulmonary Embolism Clinical Trial

Official title:
Detection of Pulmonary Embolism Comparing Isovue-370 and Visipaque 320 Using 64-Slice Multi-Detector Computed Tomographic Angiography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00351754
Other study ID # IOP 106
Secondary ID
Status Completed
Phase Phase 4
First received June 30, 2006
Last updated January 3, 2008
Start date July 2006
Est. completion date November 2006

Study information
Verified date January 2008
Source Bracco Diagnostics, Inc
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Isovue

Locations
Country Name City State
United States Bracco Diagnostics, Inc. Princeton New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hounsfield Units (HU) measured at various levels of pulmonary arteries
Secondary Presence of artifacts; global enhancement
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