Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis, Renal Insufficiency, Chronic
Conditions
Keywords
Renal Insufficiency, Angioplasty, Transluminal, Percutaneous Coronary, Contrast media
Brief summary
The purpose of this study is to demonstrate that Iodixanol 320 is associated with a lower incidence of contrast-induced nephropathy (CIN) when compared with hyperosmolar contrast medium Iomeprol 350 in patients with impaired renal function undergoing percutaneous coronary interventions (PCI).
Detailed description
Iodixanol, an iso-osmolar, dimeric, non-ionic contrast agent has been shown to reduce the risk of developing CIN in patients with elevated serum creatinine concentrations compared to low-osmolar contrast agents. However, no information is available about a potential protective effect of Iodixanol in patients with impaired renal function on CIN when used during PCI. Due to the high volume of contrast exposition, patients with impaired renal function are at increased risk for the development of CIN compared to patients with normal excretory renal function. The purpose of the investigation is to determine the changes of renal function in patients with impaired renal function receiving Iodixanol 320 or Iomeprol 350 for percutaneous coronary intervention.
Interventions
DRUGIodixanol 320
Iodixanol 320 is used as contrast media while coronary intervention.
DRUGIomeprol 350
Iomeprol 350 is used as contrast media while coronary intervention.
Sponsors
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* chronic renal failure * Informed, written consent
Exclusion criteria
* Cardiogenic shock * Dialysis * kidney transplantation * Concurrent intake of nephrotoxic medication * Planned or proceeded parenteral (i.v. or i.a.) administration of iodine-containing contrast medium at least 7 days before/after catheterization. * Contra-indications for the use of Iodixanol (e.g. allergies) * Women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding * Patient's inability to fully cooperate with the study protocol. * Previous enrollment in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization | primary hospitalization |
Secondary
| Measure | Time frame |
|---|---|
| Duration of primary hospitalization | Duration of primary hospitalization |
| Incidence of severe acute kidney failure | severe acute kidney failure |
| Contrast-induced nephropathy six months after PCI | 6 months |
| Mortality and myocardial infarction at 6 and 12 months | 6 and 12 months |
Countries
Germany
Outcome results
None listed