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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ospedale San Donato
• Collaborators: Ospedale della Misericordia - Grosseto; Ospedale Le Scotte

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