The Contrast Media and Nephrotoxicity Following Coronary Revascularization by Primary Angioplasty for Acute Myocardial Infarction. The CONTRAST-AMI Study.
Overview
- Phase
- Phase 4
- Intervention
- Iodixanol
- Conditions
- Contrast Induced Nephropathy
- Sponsor
- Ospedale San Donato
- Enrollment
- 432
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
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
Arms & Interventions
iodixanol
Iso-osmolar contrast medium (Iodixanol) will be administered during PCI
Intervention: Iodixanol
iopromide
Low-osmolar contrast medium (Iopromide) will be administered during PCI
Intervention: Iopromide
Outcomes
Primary Outcomes
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
Time Frame: days 1, 2, 3, and at discharge
Secondary Outcomes
- 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)