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

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ClinicalTrials.gov Identifier: NCT00335101
Recruitment Status : Withdrawn (Sponsor Decision to withdraw study (comparative product withdrawn from the market))
First Posted : June 8, 2006
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease (CAD) Renal Impairment Diabetes Mellitus Drug: Iodixanol, Ioversol, Iopromide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Study Start Date : June 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Primary endpoint:
  2. Maximum peak increase in SCr from baseline up to day 3.
  3. Secondary endpoints:
  4. Change in SCr from baseline to day 2 and to day 3
  5. Number of subjects with contrast-induced nephropathy (CIN)
  6. Quality of diagnostic information

Secondary Outcome Measures :
  1. Coronary Artery Disease (CAD)
  2. Renal Impairment
  3. Diabetes mellitus


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00335101     History of Changes
Other Study ID Numbers: GE-012-091
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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:
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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