Status:
COMPLETED
Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI)
Lead Sponsor:
Ospedale San Donato
Collaborating Sponsors:
Ospedale Le Scotte
Ospedale della Misericordia - Grosseto
Conditions:
Contrast Induced Nephropathy
Acute Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 pat...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
432 Patients enrolled
Trial Details
Trial ID
NCT00827788
Start Date
December 1 2008
Last Update
November 16 2010
Active Locations (1)
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1
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy, 52100