A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients

Study Overview
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Brief Summary
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The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).

Detailed Description
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In the diagnosis and treatment of coronary heart disease, patients should undergo cardiac angiography or percutaneous coronary intervention (PCI). In those procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with chronic renal insufficiency.

Official Title
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A Randomized, Double-blinded Comparison of Iopromide and Iodixanol in Renally Impaired Patients Undergoing Cardiac Catheterization

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Drug: Iopromide (Ultravist)
* Drug: Iodixanol (Visipaque)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older Plan to undergo Cardiac Catheterization Signed ICF eGFR: 30 59 mL/min/1.73m2 Exclusion Criteria: Pregnancy Under dialysis Conditions interfering with Cardiac Catheterization Participation in other trials Allergic to X-ray contrast media Administration of any investigational drug within the previous 30 days Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug Left ventricular ejection fraction (LVEF) less than 30% by ultrasound examination Intake of any nephrotoxic medications 24 hours before or after the administration of study drug

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iopromide<br>Drug: Ultravist 370 mgl/ml, injection of intra-artery during cardiac interventional operation | Drug: Iopromide (Ultravist)<br>* Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM<br>* Other names: Ultravist;|
| Active Comparator: Iodixanol<br>Drug: Visipaque 320 mgl/ml, injection of intra-artery | Drug: Iodixanol (Visipaque)<br>* Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM<br>* Other names: Visipaque;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline. |  | day 3 postreatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients developing acute renal failure. |  | day 30 postreatment | 
| Incidence of a postdose SCr increase ≧25%, a postdose SCr increase ≧1mg/dL, a postdose SCr increase ≧0.5mg/dL, a postdose eGFR decrease ≧25% |  | days 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast Induced Nephropathy, CIN, Cardiac Catheterization