Richard J. Solomon, MD, Madhu K. Natarajan, MD, Serge Doucet, MD, Samin K. Sharma, MD,
Cezar S. Staniloae, MD, Richard E. Katholi, MD, Joseph L. Gelormini, MD, Marino Labinaz, MD,
Abel E. Moreyra, MD, and the Investigators of the CARE Study
- Patients were randomized to receive either iopamidol-370 (n=204) or iodixanol-320 (n=210) as part of their scheduled cardiac catheterization
- All groups and individuals associated with the study remained blinded to the contrast agents used
- All patients received hydration with isotonic sodium bicarbonate prior, during, and for 6 hours following
the procedure; each site chose whether to administer a prophylactic N-acetylcysteine regimen
- Serum creatinine (SCr) levels and eGFR were assessed at baseline and 2-5 days postdose and repeated
on day 7 if a ≥0.5 mg/dL increase in SCr was observed
- A central laboratory (Covance, Indianapolis, IN) developed study-specific collection kits, performed
all of the baseline and postdose SCr measurements, and calculated eGFR
- The CIN endpoints were defined as a) an absolute increase in SCr ≥0.5 mg/dL (≥44.2 μmol/L) and b) incidence of a ≥25% increase in SCr or a ≥25% decrease in eGFR from baseline to 45-120 hours after contrast
Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media.
Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media.
Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events.
As with all injectable contrast agents, the possibility of severe reactions should be borne in mind, regardless of the patient’s pre-existing medical history.
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The CARE study enrolled 414 evaluable patients with moderate-to-severe chronic kidney disease (estimated glomerular filtration rate [eGFR], 20-59 mL/min/1.73 m2) undergoing diagnostic cardiac angiography or PCI.
Methods:
A prospective, multicenter, randomized, double-blind, parallel-group clinical trial to compare the renal tolerability of iopamidol-370 (370 mgI/mL) and iodixanol-320 (320 mgI/mL) in a high-risk patient population.
Study Design
Compare the incidence of contrast-induced nephropathy (CIN) following the intra-arterial administration
of iopamidol-370 or iodixanol-320 in patients with moderate-to-severe chronic kidney disease undergoing
cardiac angiography or percutaneous coronary interventions (PCI).
Objective