The purpose of this study is to determine the incidence of contrast induced nephropathy and myocardial tissue reperfusion following iso-osmolar iodixanol or ipo-osmolar iopromide administration in patients with acute myocardial infarction undergoing primary PCI.
This is a multicentric randomized comparison between iso-osmolar and ipo-osmolar contrast agents in patients treated with primary PCI with the evaluation of contrast-induced nephropathy incidence and myocardial tissue reperfusion. The study was designed as a non-inferiority trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
432
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy
Incidence of Contrast Induced Nephropathy (CIN) between the two study groups, defined as relative increase of serum Creatinine of 25% or more from basal values
Time frame: days 1, 2, 3, and at discharge
TIMI grade flow
Time frame: before and after primary PCI
Corrected TFC (TIMI frame count)
Time frame: after primary PCI
TMPG (TIMI Myocardial Perfusion Grade)
Time frame: after PCI
LFR slope (load to function slope)
Time frame: after primary PCI
MACE
Time frame: 1, 6, 12 months
absolute increase in serum Creatinine
Time frame: days 1, 2, 3, and at discharge
relative increase in serum creatinine of 50% or more
Time frame: days 1, 2, 3, and at discharge
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