Back to resultsPROMISS: Simvastatin Prevents the Contrast Induced Acute Renal Failure in Patients With Renal Insufficiency Undergoing Coronary Angiography
Primary Purpose
Kidney Failure
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Simvastatin
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Failure focused on measuring Kidney failure, Contrast media, Prevention, Simvastatin
Eligibility 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.
Sites / Locations
- Seoul National University Hospital , Cardiovascular Center
Outcomes
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.
Full Information
NCT ID
NCT00259441
First Posted
November 25, 2005
Last Updated
July 10, 2007
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00259441
Brief Title
PROMISS: Simvastatin Prevents the Contrast Induced Acute Renal Failure in Patients With Renal Insufficiency Undergoing Coronary Angiography
Official Title
Prevention of Radiocontrast Media Induced Nephropathy by Short-Term High-Dose Statin in Renal Insufficiency Undergoing Coronary Angiography (PROMISS)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure
Keywords
Kidney failure, Contrast media, Prevention, Simvastatin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
320 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Primary Outcome Measure Information:
Title
The mean peak increase of serum creatinine concentration during day1 and day2.
Secondary Outcome Measure Information:
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-Hee Oh, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hyo-Soo Kim, M.D.,Ph.D.
Organizational Affiliation
Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sang-Ho Jo, M.D.
Organizational Affiliation
Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bon-Kwon Koo, M.D.,Ph.D.
Organizational Affiliation
Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital , Cardiovascular Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
18294484
Citation
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.
Results Reference
derived
Learn more about this trial
PROMISS: Simvastatin Prevents the Contrast Induced Acute Renal Failure in Patients With Renal Insufficiency Undergoing Coronary Angiography
We'll reach out to this number within 24 hrs