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

Primary Purpose

Renal Insufficiency, Chronic, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Iodixanol 320

Iomeprol 350

About this trial

This is an interventional prevention trial for Renal Insufficiency, Chronic focused on measuring Renal Insufficiency, Angioplasty, Transluminal, Percutaneous Coronary, Contrast media

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

1. Medizinische Klinik, Klinikum rechts der Isar
Deutsches Herzzentrum Muenchen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Iodixanol 320

Iomeprol 350

Outcomes

Primary Outcome Measures

Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization

Secondary Outcome Measures

Duration of primary hospitalization

Incidence of severe acute kidney failure

Contrast-induced nephropathy six months after PCI

Mortality and myocardial infarction at 6 and 12 months

Full Information

NCT ID

NCT00390585

First Posted

October 19, 2006

Last Updated

March 12, 2010

Sponsor

Deutsches Herzzentrum Muenchen

1. Study Identification

Unique Protocol Identification Number

NCT00390585

Brief Title

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

2. Study Status

Record Verification Date

February 2008

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Insufficiency, Chronic, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis

Keywords

Renal Insufficiency, Angioplasty, Transluminal, Percutaneous Coronary, Contrast media

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

324 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Iodixanol 320

Arm Title

Arm Type

Active Comparator

Arm Description

Iomeprol 350

Intervention Type

Drug

Intervention Name(s)

Iodixanol 320

Other Intervention Name(s)

VISIPAQUE (TM)

Intervention Description

Iodixanol 320 is used as contrast media while coronary intervention.

Intervention Type

Drug

Intervention Name(s)

Iomeprol 350

Other Intervention Name(s)

Imeron

Intervention Description

Iomeprol 350 is used as contrast media while coronary intervention.

Primary Outcome Measure Information:

Title

Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization

Time Frame

primary hospitalization

Secondary Outcome Measure Information:

Title

Duration of primary hospitalization

Time Frame

Duration of primary hospitalization

Title

Incidence of severe acute kidney failure

Time Frame

severe acute kidney failure

Title

Contrast-induced nephropathy six months after PCI

Time Frame

6 months

Title

Mortality and myocardial infarction at 6 and 12 months

Time Frame

6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Albert Schoemig, MD

Organizational Affiliation

Deutsches Herzzentrum Muenchen

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Rainer Wessely, MD

Organizational Affiliation

Deutsches Herzzentrum Muenchen

Official's Role

Principal Investigator

Facility Information:

Facility Name

1. Medizinische Klinik, Klinikum rechts der Isar

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Deutsches Herzzentrum Muenchen

City

Munich

ZIP/Postal Code

80636

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

10075613

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.

Results Reference

background

PubMed Identifier

9686693

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.

Results Reference

background

PubMed Identifier

20031753

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.

Results Reference

result

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

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