PREVENTion of Contrast-Induced Nephropathy after Cardiovascular catheterization and intervention by high dose statin therapy in Japa
Not Applicable
- Conditions
- Coronary artery disease with dyslipidemia and chronic kidney disease
- Registration Number
- JPRN-UMIN000021695
- Lead Sponsor
- ara Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 420
Inclusion Criteria
Not provided
Exclusion Criteria
1. Contraindication to statin treatment 2. Contraindication to contrast medium 3. Treatment with fibrate 4. Treatment with cyclosporine 5. Severe liver dysfunction (acute hepatitis, liver cirrhosis, liver cancer, jaundice, GOT or GPT>=100IU/l) 6. Severe renal dysfunction (acute renal failure, maintenance dialysis, serum creatinine>=3mg/dl) 7. CPK>=350IU/L 8. Patients receiving high dose statin (atorvastatine;>=15mg/day,rosvastatin;>=7.5mg/day,pitavastatin;>=3mg/day) before enrollment 9. Familial hypercholesterolemia 10. Nephrotic syndrome 11. Contrast medium administration within the previous 10 days 12. Pregnant, becoming pregnant, breast feeding 13. Inadequate to this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Contrast-induced nephropathy; an increase in serum creatinine level of 0.5 mg/dL or 25% at 48 hours after contrast medium exposure
- Secondary Outcome Measures
Name Time Method 1) Acute kidney injury; an increase in serum creatinine level of 0.3 mg/dL or 50% at 48 hours after contrast medium exposure 2) Change in serum creatinine level 24 hours and 48 hours after coronary angiography 3) Urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) level and urinary NGAL/ urinary creatinine on the day, 24 hours and 48 hours after coronary angiography 4) All cause death, cardiac death, stroke, and hospitalization for heart failure at 12 moths 5) Newly required dialysis and more than 2 x baseline serum creatinine level at 12 months 6) Adverse drug reaction; myalgia, eczema, nausea, elevation of GOT or GPT, elevation of CPK