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

This study has been terminated.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00335101
First received: June 6, 2006
Last updated: May 14, 2007
Last verified: May 2007
  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
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Iodixanol
Iopromide
Ioversol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014