Coronary artery disease
Conditions
Interventions
iodixanol-320:Intravascular injection with iodixanol-320
iohexol -350:Intravascular injection with iohexol -350
Sponsors
Nanjing First Hospital, Nanjing Medical Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patient aged 18 to 75 years; 2. Patient (or patient’s legally-authorized representative) understands the trial requirements and treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed; 3. Patient is eligible for PCI; 4. Patient has stable/unstable angina or silent myocardial ischemia , when biomarker levels are stable normal on 2 samples that are within 24 hours before PCI; 5. Patient is an acceptable candidate for coronary artery bypass grafting (CABG); 6. Patient is willing to comply with all protocol-required follow-up evaluations; 7. Baseline serum creatinine male 80 ml/min; 9. BUN <8.2mmol/L.
Exclusion criteria
Exclusion criteria: 1. Patient with biomarker levels are stable abnormal within 24 hours before PCI; 2. Patient with isolated kidney, transplant kidney, bilateral renal artery stenosis; 3. Patient with severe liver disfunction, serious infections; 4. Patient has known allergy to the drug-eluting stent system or protocol-required concomitant medications(history of anaphylaxis to iodinated contrast medium); 5. Patient has intolerable to dual anti-platelet therapy; 6. Patient is a woman who is pregnant or nursing; 7. Patient with chronic kidney disease (GFR < 60 ml/min / 1.73 m2); 8. Patient had intraarterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of the study agents; 9. Patient had substantially decreased the chances to obtain reliable data (New York Heart Association class IV congestive heart failure, hypersensitivity to iodine-containing compounds, hyperthyroidism or thyroid malignancies, uncontrolled diabetes mellitus, unstable renal function, drug dependence, psychiatric disorders, dementia); 10. Patient administration of any medication to prevent CIN other than N-acetylcysteine (NAC), or intake of nephrotoxic medications from 24 hours before to 24 hours after the administration of the study agent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TNI;CK-MB; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cystatin C;NGAL;IL-18;KIM-1;L-FAB; | — |
Countries
China
Contacts
Public ContactShao-Liang Chen
Outcome results
None listed