The contrast media and nephrotoxicity following coronary revascularization by primary angioplasty for acute myocardial infarction study: design and rationale of the CONTRAST-AMI study.
BACKGROUND
Contrast-induced acute kidney injury (CI-AKI) is a complex syndrome of acute renal failure occurring after the administration of contrast media and contributing to prolonged hospital stay and mortality. The risk of CI-AKI is higher among patients undergoing primary percutaneous coronary interventions for acute myocardial infarction (AMI), but its clinical relevance in such setting has only been evaluated by small sample size single-center studies and retrospective or observational analyses. Furthermore, whereas high-osmolar contrast media was shown to have direct nephrotoxicity, the role of low-osmolar and iso-osmolar agents is still debated.


METHODS
The CONTRAST-AMI study is a prospective, multicenter, controlled, randomized, single-blind, parallel-group trial, designed to show the noninferiority of the effects of iopromide (low-osmolar) compared with iodixanol (iso-osmolar) contrast media on the incidence of CI-AKI and tissue-level perfusion in patients with AMI. All consecutive patients admitted to participating centers for ST-segment elevation AMI undergoing primary percutaneous coronary intervention will be enrolled. All patients will be treated with high-dose N-acetylcysteine (1200 mg intravenously during the procedure and 1200 mg orally two times daily for the next 48 h after percutaneous coronary intervention) and hydration according to a standardized protocol. The primary endpoint is the proportion of patients with a relative increase in serum creatinine (sCr) of at least 25% from baseline to 72 h after agent administration. The secondary endpoints are absolute and relative increases in sCr of at least 50%, thrombolysis in myocardial infarction (TIMI) perfusion grade, and major adverse cardiac events at 1, 6, and 12 months.


CONCLUSIONS
The CONTRAST-AMI study will provide information on the effects of iodixanol and iopromide on the incidence of CI-AKI and tissue-level perfusion in patients with AMI.
Bolognese
Leonardo
L
Cardiovascular Department, San Donato Hospital, Arezzo, Italy. leonardobolognese@hotmail.com
Falsini
Giovanni
G
Grotti
Simone
S
Limbruno
Ugo
U
Liistro
Francesco
F
Carrera
Arcangelo
A
Angioli
Paolo
P
Picchi
Andrea
A
Ducci
Kenneth
K
Pierli
Carlo
C
D000111:Acetylcysteine / Q000008:administration & dosage; D058186:Acute Kidney Injury / Q000097:blood / Q000139:chemically induced* / Q000517:prevention & control; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D015415:Biomarkers / Q000097:blood; D003287:Contrast Media / Q000009:adverse effects*; D017023:Coronary Angiography / Q000009:adverse effects*; D003404:Creatinine / Q000097:blood; D006331:Heart Diseases / Q000209:etiology; D006801:Humans; D007472:Iohexol / Q000009:adverse effects / Q000031:analogs & derivatives*; D007558:Italy; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000628:therapy*; D011446:Prospective Studies; D012107:Research Design; D016037:Single-Blind Method; D013577:Syndrome; D013997:Time Factors; D016896:Treatment Outcome; D014283:Triiodobenzoic Acids / Q000009:adverse effects*
D015415:Biomarkers; D003287:Contrast Media; D014283:Triiodobenzoic Acids; D007472:Iohexol; C038192:iopromide; D003404:Creatinine; C044834:iodixanol; D000111:Acetylcysteine