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

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.
ClinicalTrials.gov Identifier: NCT00209430
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 31, 2007
Sponsor:
Information provided by:
GE Healthcare

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Renal Impairment Drug: Iodixanol 320 mgI/mL Phase 4

Detailed Description:
GEHC has decided not to provide this detail

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.
Study Start Date : August 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Iodixanol
U.S. FDA Resources




Primary Outcome Measures :
  1. Peak increase in SCr
  2. Incidence of contrast media-induced nephropathy from baseline up to day 3.

Secondary Outcome Measures :
  1. SCr concentrations up to days 3 and 7
  2. image quality
  3. occurrence of adverse events and their severity and relationship with the contrast media.


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 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.

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): NCT00209430


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00209430     History of Changes
Other Study ID Numbers: DXV405
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 2007

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases