NCT00259441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

July 12, 2007

Status Verified

July 1, 2007

First QC Date

November 25, 2005

Last Update Submit

July 10, 2007

Conditions

Kidney Failure

Keywords

Kidney failureContrast mediaPreventionSimvastatin

Outcome Measures

Primary Outcomes (1)

  • The mean peak increase of serum creatinine concentration during day1 and day2.

Secondary Outcomes (2)

  • 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.

Interventions

SimvastatinDRUG

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital , Cardiovascular Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 18294484DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Byung-Hee Oh, M.D., Ph.D.

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

    STUDY CHAIR

  • Hyo-Soo Kim, M.D.,Ph.D.

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

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 25, 2005

First Posted

November 29, 2005

Study Start

February 1, 2005

Study Completion

March 1, 2006

Last Updated

July 12, 2007

Record last verified: 2007-07

Locations

KR(1)