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

Sponsored by:	Deutsches Herzzentrum Muenchen
Information provided by:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00390585

Purpose

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
Renal Insufficiency, Chronic Angioplasty, Transluminal, Percutaneous Coronary Coronary Arteriosclerosis	Drug: Iodixanol 320 Drug: Iomeprol 350	Phase IV

MedlinePlus related topics: Angioplasty

Drug Information available for: Iodixanol Iomeprol

U.S. FDA Resources

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

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:

Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization [ Time Frame: primary hospitalization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Duration of primary hospitalization [ Time Frame: Duration of primary hospitalization ] [ Designated as safety issue: Yes ]
Incidence of severe acute kidney failure [ Time Frame: severe acute kidney failure ] [ Designated as safety issue: Yes ]
Contrast-induced nephropathy six months after PCI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Mortality and myocardial infarction at 6 and 12 months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

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	Drug: Iodixanol 320 Iodixanol 320 is used as contrast media while coronary intervention.
B: Active Comparator Iomeprol 350	Drug: Iomeprol 350 Iomeprol 350 is used as contrast media while coronary intervention.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390585

Locations

Germany
1. Medizinische Klinik, Klinikum rechts der Isar
Muenchen, Germany, 81675
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Investigators

Study Chair:	Albert Schoemig, MD	Deutsches Herzzentrum Muenchen
Principal Investigator:	Rainer Wessely, MD	Deutsches Herzzentrum Muenchen

More Information

Publications:

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.

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.

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
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:

Renal Insufficiency
Angioplasty, Transluminal, Percutaneous Coronary
Contrast media

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009