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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Iodixanol 320 |
|
| B | Active Comparator | Iomeprol 350 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodixanol 320 | Drug | Iodixanol 320 is used as contrast media while coronary intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization | primary hospitalization |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Schoemig, MD | Deutsches Herzzentrum Muenchen | Study Chair |
| Rainer Wessely, MD | Deutsches Herzzentrum Muenchen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum Muenchen | Munich | 80636 | Germany | |||
| 1. Medizinische Klinik, Klinikum rechts der Isar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10075613 | Background | Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002. | |
| 9686693 | Background |
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| Iomeprol 350 | Drug | Iomeprol 350 is used as contrast media while coronary intervention. |
|
|
| 6 months |
| Mortality and myocardial infarction at 6 and 12 months | 6 and 12 months |
| München |
| 81675 |
| Germany |
| Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S. |
| 20031753 | Result | Wessely R, Koppara T, Bradaric C, Vorpahl M, Braun S, Schulz S, Mehilli J, Schomig A, Kastrati A; Contrast Media and Nephrotoxicity Following Coronary Revascularization by Angioplasty Trial Investigators. Choice of contrast medium in patients with impaired renal function undergoing percutaneous coronary intervention. Circ Cardiovasc Interv. 2009 Oct;2(5):430-7. doi: 10.1161/CIRCINTERVENTIONS.109.874933. Epub 2009 Sep 22. |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003324 | Coronary Artery Disease |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C044834 | iodixanol |
| C057937 | iomeprol |
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