Iodixanol vs. Iomeprol to Prevent Contrast-Induced Nephropathy After Coronary Intervention (CONTRAST)

Renal Insufficiency, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390585
• Other study ID #: GE IDE No. E00605
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2006
• Last updated: March 12, 2010
• Start date: July 2006
• Est. completion date: December 2008

Study information

• Verified date: February 2008
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: December 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Angioplasty, Transluminal, Percutaneous Coronary
• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Iodixanol 320
Iodixanol 320 is used as contrast media while coronary intervention.
• Iomeprol 350
Iomeprol 350 is used as contrast media while coronary intervention.

Locations

Country	Name	City	State
Germany	1. Medizinische Klinik, Klinikum rechts der Isar	Muenchen
Germany	Deutsches Herzzentrum Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View Citation

Wessely R, Koppara T, Bradaric C, Vorpahl M, Braun S, Schulz S, Mehilli J, Schömig A, Kastrati A; Contrast Media and Nephrotoxicity Following Coronary Revascularization by Angioplasty Trial Investigators. Choice of contrast medium in patients with impaire — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization		primary hospitalization	Yes
Secondary	Duration of primary hospitalization		Duration of primary hospitalization	Yes
Secondary	Incidence of severe acute kidney failure		severe acute kidney failure	Yes
Secondary	Contrast-induced nephropathy six months after PCI		6 months	Yes
Secondary	Mortality and myocardial infarction at 6 and 12 months		6 and 12 months	No