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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00259441
First received: November 25, 2005
Last updated: July 10, 2007
Last verified: July 2007
  Purpose

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.


Condition Intervention Phase
Kidney Failure
Drug: Simvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Prevention of Radiocontrast Media Induced Nephropathy by Short-Term High-Dose Statin in Renal Insufficiency Undergoing Coronary Angiography (PROMISS)

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The mean peak increase of serum creatinine concentration during day1 and day2.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 320
Study Start Date: February 2005
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00259441

Locations
Korea, Republic of
Seoul National University Hospital , Cardiovascular Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00259441     History of Changes
Other Study ID Numbers: H-0509-517-158
Study First Received: November 25, 2005
Last Updated: July 10, 2007
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
Kidney failure
Contrast media
Prevention
Simvastatin

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 11, 2014