The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with chronic kidney disease undergoing coronary angiography.
To compare the incidence of contrast-induced nephropathy (CIN)(an absolute SCr increase 0.5 mg/dL from baseline) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with chronic kidney disease (serum creatinine level more than 1.5 mg/dL for men and more than 1.3 mg/dL for women or preprocedural estimated glomerular filtration rate(eGFR):15-60 mL/min/1.73 m2) undergoing coronary angiography.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
204
Iopamiro-370 (Iopamidol injection 76%) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution
Visipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution
Guangdong Cardiovascular Institute,Guangdong General Hospital
Guangzhou, Guangdong, China
contrast-induced nephropathy
Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl or 25% from the baseline within 48-72 h of contrast exposure
Time frame: 48-72 h
A relative increase in serum creatinine
A relative increase in serum creatinine was defined as more than 25% increase in serum creatinine within 48-72 h of contrast exposure.
Time frame: 48-72 h
A relative increase in estimated glomerular filtration rate (eGFR)
A relative increase in eGFR was defined as more than 25% increase in eGFR within 48-72 h of contrast exposure
Time frame: 48-72 h
An absolute increase in serum creatinine
An absolute increase in serum creatinine within 48-72 h of contrast exposure
Time frame: 48-72 h
Major adverse clinical events
Major adverse clinical events: death, requiring renal replacement therapy, 2nd myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke
Time frame: 1 month
Major adverse clinical events
Major adverse clinical events: death, requiring renal replacement therapy, acute myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke
Time frame: 1 year
An significant increase in serum creatinine
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An significant increase in serum creatinine was defined as an increase in serum creatinine of more than 1.0 mg/dl from the baseline within 48-72 h of contrast exposure
Time frame: 48-72 h
Contrast-Induced Acute Kidney Injury
Contrast-Induced Acute Kidney Injury was defined as an increase in serum creatinine concentration of more than 0.3 mg/dL from the baseline value at 48 hours after administration of the contrast exposure or the need for dialysis
Time frame: 48 h