Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI)
Phase 4
Completed
- Conditions
- Contrast Induced NephropathyAcute Myocardial Infarction
- Interventions
- Registration Number
- NCT00827788
- Lead Sponsor
- Ospedale San Donato
- 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 patients with acute myocardial infarction undergoing primary PCI.
- 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 myocardial tissue reperfusion. The study was designed as a non-inferiority trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 432
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description iodixanol Iodixanol Iso-osmolar contrast medium (Iodixanol) will be administered during PCI iopromide Iopromide Low-osmolar contrast medium (Iopromide) will be administered during PCI
- Primary Outcome Measures
Name Time Method 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 days 1, 2, 3, and at discharge
- Secondary Outcome Measures
Name Time Method TIMI grade flow before and after primary PCI Corrected TFC (TIMI frame count) after primary PCI TMPG (TIMI Myocardial Perfusion Grade) after PCI LFR slope (load to function slope) after primary PCI MACE 1, 6, 12 months absolute increase in serum Creatinine days 1, 2, 3, and at discharge relative increase in serum creatinine of 50% or more days 1, 2, 3, and at discharge
Trial Locations
- Locations (1)
Cardiovascular Department, Ospedale S.Donato
🇮🇹Arezzo, AR, Italy