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

Seoul National University

Status and phase

Completed

Phase 4

Conditions

Kidney Failure

Treatments

Drug: Simvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00259441

H-0509-517-158

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.