PROMISS: Simvastatin Prevents the Contrast Induced Acute Renal Failure in Patients With Renal Insufficiency Undergoing Coronary Angiography
The contrast induced kidney toxicity has been known to affect the mortality and morbidity in the patients undergoing coronary angiography. But the mechanism and therapeutic strategy for it is not well known. Nowadays, it is reported that the N-acetylcysteine may have preventive effects for contrast induced kidney toxicity with its antioxidant effects.The statins have been reported to have many other effects other than the lipid lowering effect-including antioxidant effect, so we hypothesized that the antioxidant effect of simvastatin may prevent the contrast induced kidney toxicity.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Prevention of Radiocontrast Media Induced Nephropathy by Short-Term High-Dose Statin in Renal Insufficiency Undergoing Coronary Angiography (PROMISS)|
- The mean peak increase of serum creatinine concentration during day1 and day2.
- Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L) during days 1 and 2.
- Proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L), the proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine, and the mean peak increase in serum creatinine.
|Study Start Date:||February 2005|
|Estimated Study Completion Date:||March 2006|
The simvastatin may prevent the contrast agent induced acute renal failure in the patients with underlying renal insufficiency who is undergoing the coronary angiography. The effect may derive from the antioxidant function of simvastatin.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259441
|Korea, Republic of|
|Seoul National University Hospital , Cardiovascular Center|
|Seoul, Korea, Republic of|
|Study Chair:||Byung-Hee Oh, M.D., Ph.D.||Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center|
|Study Director:||Hyo-Soo Kim, M.D.,Ph.D.||Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center|
|Principal Investigator:||Sang-Ho Jo, M.D.||Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center|
|Principal Investigator:||Bon-Kwon Koo, M.D.,Ph.D.||Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center|