Trials / Completed
CompletedNCT00390585
Iodixanol vs. Iomeprol to Prevent Contrast-Induced Nephropathy After Coronary Intervention (CONTRAST)
Prospective, Randomized, Comparative Study to Evaluate the Effect of Iodixanol 320 Compared to Iomeprol 350 on Contrast Medium Induced Nephropathy in Patients With Impaired Renal Function Undergoing PCI
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 324 (actual)
- Sponsor
- Deutsches Herzzentrum Muenchen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Renal Insufficiency, Chronic
- Angioplasty, Transluminal, Percutaneous Coronary
- Coronary Arteriosclerosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Iodixanol 320 | Iodixanol 320 is used as contrast media while coronary intervention. |
| DRUG | Iomeprol 350 | Iomeprol 350 is used as contrast media while coronary intervention. |
Timeline
- Start date
- 2006-07-01
- Primary completion
- 2008-01-01
- Completion
- 2008-12-01
- First posted
- 2006-10-20
- Last updated
- 2010-03-15
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00390585. Inclusion in this directory is not an endorsement.