A Phase 4 interventional study of Iodixanol 320 and Iomeprol 350 in Renal Insufficiency, Chronic, Angioplasty, Transluminal, Percutaneous Coronary and Coronary Arteriosclerosis, sponsored by Deutsches Herzzentrum Muenchen. Completed at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-03-15.
Sponsored by Deutsches Herzzentrum Muenchen · Phase 4, Interventional, and Prevention
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).
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.
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's enrollment of 324 is above the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Deutsches Herzzentrum Muenchen is the lead sponsor of 114 studies on the registry; 10 are open to participants now.
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Iodixanol 320
Drug: Iodixanol 320
Iomeprol 350
Drug: Iomeprol 350
Iodixanol 320 is used as contrast media while coronary intervention.
Also known as: VISIPAQUE (TM)
Iomeprol 350 is used as contrast media while coronary intervention.
Also known as: Imeron
Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization
Time frame: primary hospitalization
Duration of primary hospitalization
Time frame: Duration of primary hospitalization
Incidence of severe acute kidney failure
Time frame: severe acute kidney failure
Contrast-induced nephropathy six months after PCI
Time frame: 6 months
Mortality and myocardial infarction at 6 and 12 months
Time frame: 6 and 12 months
The record gives a start of Jul 2006, a primary completion of Jan 2008 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Iodixanol
Renal Insufficiency, Chronic →
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