NCT00926562

A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients

A Randomized, Double-blinded Comparison of Iopromide and Iodixanol in Renally Impaired Patients Undergoing Cardiac Catheterization

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 592 (actual)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).

Detailed description

In the diagnosis and treatment of coronary heart disease, patients should undergo cardiac angiography or percutaneous coronary intervention (PCI). In those procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with chronic renal insufficiency.

Conditions

• Kidney Failure, Chronic

Interventions

Type	Name	Description
DRUG	Iopromide (Ultravist)	Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM
DRUG	Iodixanol (Visipaque)	Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-12-01
• Completion: 2011-05-01
• First posted: 2009-06-23
• Last updated: 2011-06-27

Locations

19 sites across 1 country: China