Contrast-medium Induced Nephrotoxicity in Patients Undergoing Coronary Angiography - Iodixanol Versus Iopromide

Study Overview
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Brief Summary
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In the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography, coronary balloon intervention and stenting intervention are the mainstay of therapy in recent years. In that procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. The investigators intended to find out which contrast agent has less kidney toxicity in the catheter based treatment of coronary arterial diseases in patients with underlying decreased kidney function

Detailed Description
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Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than nonionic, monomeric, low-osmolar contrast media (LOCMs) in high-risk patients. We compared the nephrotoxicity of iodixanol with that of iopromide, an nonionic, monomeric LOCM, in patients with renal impairment.

Official Title
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Comparison of Contrast-medium Induced Nephrotoxicity Between Iodixanol and Iopromide in Patients With Renal Insufficiency Undergoing Coronary Angiography

Conditions
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Chronic Renal Insufficiency, Coronary Angiography

Intervention / Treatment
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* Drug: contrast agent (iopromide)
* Drug: contrast agent (iodixanol)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who undergo coronary catheterization creatinine clearance rates ≤ 60 mL/min using the Cockcroft-Gault formula Exclusion Criteria: pregnancy or lactation having received contrast media within 7 days of study entry emergent coronary angiography acute renal failure or end-stage renal disease requiring dialysis history of hypersensitivity reaction to contrast media unstable hemodynamic states such as cardiogenic shock, pulmonary edema or needing mechanical ventilation multiple myeloma parenteral use of diuretics use of N-acetylcysteine use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: iopromide<br> | Drug: contrast agent (iopromide)<br>* coronary angiography using the allocated contrast agent<br>|
| Experimental: iodixanol<br> | Drug: contrast agent (iodixanol)<br>* coronary angiography using the allocated contrast agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L) |  | days 1 and 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L), the proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine, and the mean peak increase in serum creatinine |  | days 1 and 2 |