Back to resultsRenal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography
Primary Purpose
Coronary Artery Disease (CAD), Renal Impairment, Diabetes Mellitus
Status
Withdrawn
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Iodixanol, Ioversol, Iopromide
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease (CAD) focused on measuring Coronary Artery Disease (CAD), Renal Impairment, Serum creatinine (SCr), Iodixanol, Ioversol, Iopromide, Contrast Induced Nephropathy (CIN)
Eligibility Criteria
Inclusion Criteria: Subjects with a combination of DM (type I or II) and renal impairment (RI), defined as 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 transplantation or with CrCl < 20 mL/min will not be included.
Sites / Locations
- GE Healthcare
- GE Healthcare
Outcomes
Primary Outcome Measures
Primary endpoint:
Maximum peak increase in SCr from baseline up to day 3.
Secondary endpoints:
Change in SCr from baseline to day 2 and to day 3
Number of subjects with contrast-induced nephropathy (CIN)
Quality of diagnostic information
Secondary Outcome Measures
Coronary Artery Disease (CAD)
Renal Impairment
Diabetes mellitus
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00335101
Brief Title
Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor Decision to withdraw study (comparative product withdrawn from the market)
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
4. Oversight
5. Study Description
Brief Summary
The study is to evaluate and compare the effects on kidney function of three iodinated contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr) concentrations up to three days after CM administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD), Renal Impairment, Diabetes Mellitus
Keywords
Coronary Artery Disease (CAD), Renal Impairment, Serum creatinine (SCr), Iodixanol, Ioversol, Iopromide, Contrast Induced Nephropathy (CIN)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Iodixanol, Ioversol, Iopromide
Primary Outcome Measure Information:
Title
Primary endpoint:
Title
Maximum peak increase in SCr from baseline up to day 3.
Title
Secondary endpoints:
Title
Change in SCr from baseline to day 2 and to day 3
Title
Number of subjects with contrast-induced nephropathy (CIN)
Title
Quality of diagnostic information
Secondary Outcome Measure Information:
Title
Coronary Artery Disease (CAD)
Title
Renal Impairment
Title
Diabetes mellitus
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with a combination of DM (type I or II) and renal impairment (RI), defined as 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 transplantation or with CrCl < 20 mL/min will not be included.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Pignot, PhD
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Johnny Gibbs, Jr., CCRA
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GE Healthcare
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
GE Healthcare
City
Munich
ZIP/Postal Code
80807
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography
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