Status:
COMPLETED
Contrast-medium Induced Nephrotoxicity in Patients Undergoing Coronary Angiography - Iodixanol Versus Iopromide
Lead Sponsor:
Seoul National University Bundang Hospital
Conditions:
Chronic Renal Insufficiency
Coronary Angiography
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
In the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography, coronary balloon intervention and sten...
Detailed Description
Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than nonionic, monomeric, low-osmolar contrast media (LOCMs) in high-risk patients. We compared the nephroto...
Eligibility Criteria
Inclusion
- patients who undergo coronary catheterization
- creatinine clearance rates ≤ 60 mL/min using the Cockcroft-Gault formula
Exclusion
- pregnancy or lactation
- having received contrast media within 7 days of study entry
- emergent coronary angiography
- acute renal failure or end-stage renal disease requiring dialysis
- history of hypersensitivity reaction to contrast media
- unstable hemodynamic states such as cardiogenic shock, pulmonary edema or needing mechanical ventilation
- multiple myeloma
- parenteral use of diuretics
- use of N-acetylcysteine
- use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00823628
Start Date
February 1 2009
End Date
June 1 2010
Last Update
July 7 2010
Active Locations (1)
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1
Cardiovascular Center, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707