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Sponsored by: |
Deutsches Herzzentrum Muenchen |
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Information provided by: | Deutsches Herzzentrum Muenchen |
ClinicalTrials.gov Identifier: | NCT00390585 |
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).
Condition | Intervention | Phase |
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Renal Insufficiency, Chronic Angioplasty, Transluminal, Percutaneous Coronary Coronary Arteriosclerosis |
Drug: Iodixanol 320 Drug: Iomeprol 350 |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study |
Official Title: | 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 |
Enrollment: | 324 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | December 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Iodixanol 320
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Drug: Iodixanol 320
Iodixanol 320 is used as contrast media while coronary intervention.
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B: Active Comparator
Iomeprol 350
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Drug: Iomeprol 350
Iomeprol 350 is used as contrast media while coronary intervention.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
1. Medizinische Klinik, Klinikum rechts der Isar | |
Muenchen, Germany, 81675 | |
Deutsches Herzzentrum Muenchen | |
Munich, Germany, 80636 |
Study Chair: | Albert Schoemig, MD | Deutsches Herzzentrum Muenchen |
Principal Investigator: | Rainer Wessely, MD | Deutsches Herzzentrum Muenchen |
Responsible Party: | Deutsches Herzzentrum Munich ( Prof. A. Schömig ) |
Study ID Numbers: | GE IDE No. E00605 |
Study First Received: | October 19, 2006 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00390585 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Renal Insufficiency Angioplasty, Transluminal, Percutaneous Coronary Contrast media |
Arterial Occlusive Diseases Coronary Disease Renal Insufficiency Heart Diseases Urologic Diseases Renal Insufficiency, Chronic |
Myocardial Ischemia Vascular Diseases Ischemia Arteriosclerosis Kidney Diseases Coronary Artery Disease |
Coronary Disease Arterial Occlusive Diseases Renal Insufficiency Heart Diseases Urologic Diseases Renal Insufficiency, Chronic |
Myocardial Ischemia Vascular Diseases Cardiovascular Diseases Kidney Diseases Arteriosclerosis Coronary Artery Disease |