Safety and Effectiveness of Visipaque 320mg-I/ml for Use in Contrast-Enhanced CT Angiography of Arteries of the Heart
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|ClinicalTrials.gov Identifier: NCT00335335|
Recruitment Status : Terminated (Sponsor decision due to low subject recrcuitment)
First Posted : June 9, 2006
Last Update Posted : April 25, 2019
CT (computed tomography) angiography (CTA) is an examination similar to a CAT scan that uses x-rays and a contrast medium (also called dye) to visualize blood flow in arteries and veins throughout the body.
VISIPAQUE™ will be given through a vein in the arm before having the CTA scan of the heart arteries. The pictures it produces of the heart and its blood vessels will be reviewed and compared to those obtained during the catheter-based coronary angiography to see if the CTA shows the same blockages.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: iodixanol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3, Open-label, Multicenter Studies to Determine Efficacy and Safety of VISIPAQUETM (Iodixanol) Injection for Use in Intravenous Contrast-Enhanced CT Angiography of Coronary Arteries|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||December 2, 2006|
|Actual Study Completion Date :||December 2, 2006|
Experimental: Visipaque Injection
All participants will receive intravenous (IV) administration of 80 mL Visipaque (iodixanol) 320 mg-I/mL at a rate of 4-5 mL per second via power injector followed by a saline injection of 40-50 mL 0.9% sodium chloride solution at a rate of 4-5 mL per second.
Other Name: Visipaque
- To evaluate diagnostic performance and safety of Visipaque-enhanced CTA images for determination of presence or absence of coronary artery obstruction [ Time Frame: 48 hours ]
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): NCT00335335
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|Study Director:||Veronica Reichl||GE Healthcare|