Status:
UNKNOWN
Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction
Lead Sponsor:
Gachon University Gil Medical Center
Collaborating Sponsors:
Gangnam Severance Hospital
Severance Hospital
Conditions:
Contrast-induced Nephropathy
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
Contrast-induced nephropathy (CIN) is a well-recognized complication of radiographic contrast administration and is associated with increased short- and long-term mortality. Previous strategies includ...
Eligibility Criteria
Inclusion
- Age ≥ 19 years
- Need for coronary angiography or intervention in patients with typical symptoms for angina or myocardial infarction, or documented myocardial ischemia at non-invasive studies including ECG, treadmill ECG test, heart spect or coronary CT angiography
- Estimated glomerular filtration rate ≤60 mL/min
- Informed consent
Exclusion
- Need for primary percutaneous coronary intervention or emergent intervention in patients with myocardial infarction
- Allergic reaction for contrast agent (Visipaque) or statin
- Contraindication for contrast agent (Visipaque) or statin
- Shock status fron any cause including cardiogenic shock
- Statin use before enrollment (Enrollment after 2 weeks of wash-out period)
- Exposure of contrast agent within 7 days before enrollment
- Pregnancy or Expectation for pregnancy in women of childbearing age
- Heart failure (NYHA class ≥3 or left ventricular ejection fraction \< 40%)
- Acute renal injury
- Dialysis therapy
- Mechanical ventilator
- Life expectancy \< 6 months
- Non-steroidal anti-inflammatory drug, dopamine, mannitol or N-acetylcysteine, ascorbic acid within 48 hours before and after coronary angiography/intervention
- Severe hepatic dysfunction
- Eisenmenger syndrome or idiopathic pulmonary hypertension
- Renal artery angioplasty within 6 months
- Single functioning kidney
- Kidney transplantation
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2014
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT01871792
Start Date
June 1 2013
End Date
February 1 2014
Last Update
June 7 2013
Active Locations (1)
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1
Gachon University Gil Hospital
Incheon, South Korea, 405-760