Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography

This study has been terminated.
Information provided by:
GE Healthcare Identifier:
First received: June 6, 2006
Last updated: May 14, 2007
Last verified: May 2007
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.

Condition Intervention Phase
Coronary Artery Disease (CAD)
Renal Impairment
Diabetes Mellitus
Drug: Iodixanol, Ioversol, Iopromide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic

Resource links provided by NLM:

Further study details as provided by GE Healthcare:

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

Estimated Enrollment: 384
Study Start Date: June 2006

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00335101

United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
GE Healthcare
Munich, Germany, 80807
Sponsors and Collaborators
GE Healthcare
Study Director: Marc Pignot, PhD GE Healthcare
Study Director: Johnny Gibbs, Jr., CCRA GE Healthcare
  More Information Identifier: NCT00335101     History of Changes
Other Study ID Numbers: GE-012-091 
Study First Received: June 6, 2006
Last Updated: May 14, 2007
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Austria: Federal Ministry for Health and Women

Keywords provided by GE Healthcare:
Coronary Artery Disease (CAD), Renal Impairment, Serum creatinine (SCr), Iodixanol, Ioversol, Iopromide, Contrast Induced Nephropathy (CIN)

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Renal Insufficiency
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Kidney Diseases
Urologic Diseases
Vascular Diseases processed this record on May 26, 2016