PROMISS: Simvastatin Prevents the Contrast Induced Acute Renal Failure in Patients With Renal Insufficiency Undergoing Coronary Angiography

Phase 4

Completed

• Conditions: Kidney Failure

• Registration Number: NCT00259441
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-11-25
• Study First Submitted QC: 2005-11-25
• Study First Posted: 2005-11-29
• Study Completion: 2006-03
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-10
• Last Update Posted: 2007-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Angina patients
• Patients who is required the coronary catheterization
• creatinine clearance rates ≤60 mL/min using the Cockcroft-Gault formula Patients who undergo coronary catheterization
• Age of 19 or over 19

Exclusion Criteria

• pregnancy
• lactation
• having received contrast media within 7 days of study entry
• emergent coronary angiography
• acute renal failure
• end-stage renal disease requiring dialysis
• history of hypersensitivity reaction to contrast media
• cardiogenic shock
• pulmonary edema
• multiple myeloma
• mechanical ventilation
• parenteral use of diuretics
• use of N-acetylcysteine
• use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The mean peak increase of serum creatinine concentration during day1 and day2.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Seoul National University Hospital , Cardiovascular Center; 🇰🇷 Seoul, Korea, Republic of