Renal Safety of Iopamidol Versus Iodixanol During Coronary Angiography in Diabetic Patients

Exclusion Criteria

• •Is a pregnant or lactating female. Exclude the possibility of pregnancy: by laboratory testing on-site at the institution (measurement of serum or urine beta human chorionic gonadotropin) within 24 hours prior to the start of investigational product administration by history (e.g., tubal ligation or hysterectomy, post menopausal with a minimum 1 year without menses)
• •Has a history of hypersensitivity to iodine-containing compounds;
• •Has unstable renal function (i.e., acute worsening of renal function, as determined by the Investigator, that has been observed in the 7 days prior to enrollment) and/or is in acute renal failure;
• •Has stage 5 chronic kidney disease or end-stage renal disease (i.e., estimated glomerular filtration rate \[eGFR\] \<15 mL/min/1.73 m2)
• •Has severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association (NYHA);
• •Has uncontrolled diabetes, as determined by the Investigator;
• •Has received an iodinated contrast agent within 7 days prior to the administration of the study agent or is scheduled to receive an iodinated contrast agent within 72 hours after administration of the study agent;
• •Is receiving cyclo-oxygenase-2 inhibitors, nonsteroidal anti-inflammatory drugs (with exception of low dose aspirin \[≤325 mg per day\]), aminoglycosides, or any other drugs that carry a significant risk of nephrotoxicity (in the opinion of the Investigator) during the time period beginning within 72 hours prior to contrast administration and up to 72 hours postdose;
• •Prior to, during or post the cardiac angiography, is receiving or will be receiving a prophylactic medication to prevent acute kidney injury that is not permitted by this protocol (e.g., theophylline, fenoldopam, etc.);
• •During cardiac angiography, is going to receive provocative pharmacological agents such as adenosine or dipyridamole;
• •Is planned to undergo major surgery (e.g. coronary artery bypass graft, valve surgery, etc.) within 48-72 hours after contrast administration;
• •Is planned to receive an intravenous diuretic or mannitol as prophylaxis to prevent acute renal injury (Note: chronic administration is allowed);
• •Is hemodynamically unstable within 48 hours pre-contrast administration defined as a systolic blood pressure \<90 mmHg or requires pressor or intra-aortic balloon support;
• •Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations;
• •Is determined by the Investigator that the patient is clinically unsuitable for the study Note: Changes in diuretics, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers doses within 72 hours prior to and up to 72 hours post contrast administration should be avoided unless clinically necessary for the subject's underlying medical condition.