Chronic Renal Insufficiency, Coronary Angiography
Conditions
Brief summary
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
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.
Interventions
DRUGcontrast agent (iopromide)
coronary angiography using the allocated contrast agent
DRUGcontrast agent (iodixanol)
coronary angiography using the allocated contrast agent
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
South Korea
Outcome results
None listed