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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Iodixanol 320

Group Type EXPERIMENTAL

Iodixanol 320

Intervention Type DRUG

Iodixanol 320 is used as contrast media while coronary intervention.

B

Iomeprol 350

Group Type ACTIVE_COMPARATOR

Iomeprol 350

Intervention Type DRUG

Iomeprol 350 is used as contrast media while coronary intervention.

Interventions

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Iodixanol 320

Iodixanol 320 is used as contrast media while coronary intervention.

Intervention Type DRUG

Iomeprol 350

Iomeprol 350 is used as contrast media while coronary intervention.

Intervention Type DRUG

Other Intervention Names

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VISIPAQUE (TM) Imeron

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No