Clinical trial NCT00390585: Iodixanol vs. Iomeprol to Prevent Contrast-Induced Nephropathy After Coronary Intervention (CONTRAST)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Insufficiency, Chronic
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Arteriosclerosis
Keywords: Renal Insufficiency
Angioplasty, Transluminal, Percutaneous Coronary
Contrast media
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2006-10-20
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization
timeFrame: primary hospitalization
Secondary outcomes:
measure: Duration of primary hospitalization
timeFrame: Duration of primary hospitalization
measure: Incidence of severe acute kidney failure
timeFrame: severe acute kidney failure
measure: Contrast-induced nephropathy six months after PCI
timeFrame: 6 months
measure: Mortality and myocardial infarction at 6 and 12 months
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: 1. Medizinische Klinik, Klinikum rechts der Isar
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Albert Schoemig, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Rainer Wessely, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.