Back to resultsRenal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography
Primary Purpose
Coronary Artery Disease, Renal Impairment
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Iodixanol 320 mgI/mL
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Iodixanol, Iopamidol, coronary angiography, Contrast media-induced nephropathy
Eligibility Criteria
Inclusion Criteria: Subjects with a combination of diabetes mellitus (type I or II) and renal impairment, defined as serum creatinine (SCr ) ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤ 50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI. Exclusion Criteria: Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplant will not be included.
Sites / Locations
- Amersham Health S.A
Outcomes
Primary Outcome Measures
Peak increase in SCr
Incidence of contrast media-induced nephropathy from baseline up to day 3.
Secondary Outcome Measures
SCr concentrations up to days 3 and 7
image quality
occurrence of adverse events and their severity and relationship with the contrast media.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00209430
Brief Title
Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography
Official Title
GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GE Healthcare
4. Oversight
5. Study Description
Brief Summary
The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
Detailed Description
GEHC has decided not to provide this detail
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Renal Impairment
Keywords
Iodixanol, Iopamidol, coronary angiography, Contrast media-induced nephropathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
408 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Iodixanol 320 mgI/mL
Primary Outcome Measure Information:
Title
Peak increase in SCr
Title
Incidence of contrast media-induced nephropathy from baseline up to day 3.
Secondary Outcome Measure Information:
Title
SCr concentrations up to days 3 and 7
Title
image quality
Title
occurrence of adverse events and their severity and relationship with the contrast media.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with a combination of diabetes mellitus (type I or II) and renal impairment, defined as serum creatinine (SCr ) ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤ 50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI.
Exclusion Criteria:
Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplant will not be included.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Widlund, BSc RN
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Johnny Gibbs, Jr., B.S., CCRA
Organizational Affiliation
609-514-6809
Official's Role
Study Director
Facility Information:
Facility Name
Amersham Health S.A
City
Solna
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
19853704
Citation
Laskey W, Aspelin P, Davidson C, Rudnick M, Aubry P, Kumar S, Gietzen F, Wiemer M; DXV405 Study Group. Nephrotoxicity of iodixanol versus iopamidol in patients with chronic kidney disease and diabetes mellitus undergoing coronary angiographic procedures. Am Heart J. 2009 Nov;158(5):822-828.e3. doi: 10.1016/j.ahj.2009.08.016.
Results Reference
derived
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Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography
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