A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese PLA General Hospital

Criteria

Inclusion Criteria:

• 18 years old or older

• Plan to undergo Cardiac Catheterization

• Signed ICF

• eGFR: 30~59 mL/min/1.73m2

Exclusion Criteria:

• Pregnancy

• Under dialysis

• Conditions interfering with Cardiac Catheterization

• Participation in other trials

• Allergic to X-ray contrast media

• Administration of any investigational drug within the previous 30 days

• Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug

• Left ventricular ejection fraction (LVEF) less than 30% by ultrasound examination

• Intake of any nephrotoxic medications 24 hours before or after the administration of study drug