Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography
Phase 4
Withdrawn
- Conditions
- Coronary Artery Disease (CAD)Renal ImpairmentDiabetes Mellitus
- Registration Number
- NCT00335101
- Lead Sponsor
- GE Healthcare
- 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 three days after CM administration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Maximum peak increase in SCr from baseline up to day 3. Secondary endpoints: Change in SCr from baseline to day 2 and to day 3 Number of subjects with contrast-induced nephropathy (CIN) Primary endpoint: Quality of diagnostic information
- Secondary Outcome Measures
Name Time Method Coronary Artery Disease (CAD) Renal Impairment Diabetes mellitus
Trial Locations
- Locations (1)
GE Healthcare
🇩🇪Munich, Germany