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

Sponsored by:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00259441

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 IV

MedlinePlus related topics: Kidney Failure Statins

Drug Information available for: Simvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Prevention of Radiocontrast Media Induced Nephropathy by Short-Term High-Dose Statin in Renal Insufficiency Undergoing Coronary Angiography (PROMISS)

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

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

Publications indexed to this study:

Jo SH, Koo BK, Park JS, Kang HJ, Cho YS, Kim YJ, Youn TJ, Chung WY, Chae IH, Choi DJ, Sohn DW, Oh BH, Park YB, Choi YS, Kim HS. Prevention of radiocontrast medium-induced nephropathy using short-term high-dose simvastatin in patients with renal insufficiency undergoing coronary angiography (PROMISS) trial--a randomized controlled study. Am Heart J. 2008 Mar;155(3):499.e1-8. Epub 2008 Jan 30.

Study ID Numbers:	H-0509-517-158
Study First Received:	November 25, 2005
Last Updated:	July 10, 2007
ClinicalTrials.gov Identifier:	NCT00259441
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:

Kidney failure
Contrast media
Prevention
Simvastatin

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Simvastatin

Kidney Failure, Acute
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009