Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI)

Launched by OSPEDALE SAN DONATO · Jan 22, 2009

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men or women aged ≥ 18
• • Patients with ST-elevation Myocardial Infarction presenting within 12 hours after the onset of symptoms (18 hours in case of cardiogenic shock), who are scheduled to undergo primary PCI
• • Patients who have signed and dated the written informed consent form
• Exclusion Criteria:
• • Patients in pregnancy or lactation
• • Long-term dialysis
• • Administration of any investigational drug within the previous 30 days
• • Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug
• • Intake of any nephrotoxic medications 24 hours before or after the administration of study drug
• • Contraindications to the study drug or the cardiac catheterization procedure
• • Previous participation in this study
• • As the discretion of the investigator, the patient has any conditions not appropriate to the usage of iodinated contrast agent or not appropriate to undergo cardiac catheterization procedure