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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00335101
First Posted: June 8, 2006
Last Update Posted: May 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
GE Healthcare
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Double
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335101


Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Germany
GE Healthcare
Munich, Germany, 80807
Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: Marc Pignot, PhD GE Healthcare
Study Director: Johnny Gibbs, Jr., CCRA GE Healthcare
  More Information

ClinicalTrials.gov Identifier: NCT00335101     History of Changes
Other Study ID Numbers: GE-012-091
First Submitted: June 6, 2006
First Posted: June 8, 2006
Last Update Posted: May 15, 2007
Last Verified: May 2007

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:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases