Status:
WITHDRAWN
Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography
Lead Sponsor:
GE Healthcare
Conditions:
Coronary Artery Disease (CAD)
Renal Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study is to evaluate and compare the effects on kidney function of three iodinated contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr) concentrations up to t...
Eligibility Criteria
Inclusion
- Subjects with a combination of DM (type I or II) and renal impairment (RI), defined as SCr ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI.
Exclusion
- Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplantation or with CrCl \< 20 mL/min will not be included.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00335101
Start Date
June 1 2006
Last Update
April 29 2019
Active Locations (2)
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1
GE Healthcare
Princeton, New Jersey, United States, 08540
2
GE Healthcare
Munich, Germany, 80807