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Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography

This study has been completed.
Information provided by:
GE Healthcare Identifier:
First received: September 13, 2005
Last updated: October 30, 2007
Last verified: October 2007
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.

Condition Intervention Phase
Coronary Artery Disease Renal Impairment Drug: Iodixanol 320 mgI/mL Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.

Resource links provided by NLM:

Further study details as provided by GE Healthcare:

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.

Estimated Enrollment: 408
Study Start Date: August 2005
Detailed Description:
GEHC has decided not to provide this detail

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00209430

Amersham Health S.A
Solna, Sweden
Sponsors and Collaborators
GE Healthcare
Study Director: Caroline Widlund, BSc RN GE Healthcare
Study Director: Johnny Gibbs, Jr., B.S., CCRA 609-514-6809
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00209430     History of Changes
Other Study ID Numbers: DXV405
Study First Received: September 13, 2005
Last Updated: October 30, 2007

Keywords provided by GE Healthcare:
coronary angiography
Contrast media-induced nephropathy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases processed this record on July 25, 2017