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

NCT ID: NCT00259441

Last Updated: 2007-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-03-31

Brief Summary

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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

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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.

Conditions

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Kidney Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Simvastatin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Byung-Hee Oh, M.D., Ph.D.

Role: STUDY_CHAIR

Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center

Hyo-Soo Kim, M.D.,Ph.D.

Role: STUDY_DIRECTOR

Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center

Sang-Ho Jo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center

Bon-Kwon Koo, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center

Locations

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Seoul National University Hospital , Cardiovascular Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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. doi: 10.1016/j.ahj.2007.11.042. Epub 2008 Jan 30.

Reference Type DERIVED
PMID: 18294484 (View on PubMed)

Other Identifiers

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H-0509-517-158

Identifier Type: -

Identifier Source: org_study_id