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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Contrast Media and Nephrotoxicity Following Coronary Revascularization by Primary Angioplasty for Acute Myocardial Infarction. The CONTRAST-AMI Study.

Conditions
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Contrast Induced Nephropathy, Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Iodixanol
* Drug: Iopromide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: iodixanol<br>Iso-osmolar contrast medium (Iodixanol) will be administered during PCI | Drug: Iodixanol<br>* Iso-osmolar contrast medium (Iodixanol) will be administered during PCI<br>* Other names: Visipaque®;|
| Active Comparator: iopromide<br>Low-osmolar contrast medium (Iopromide) will be administered during PCI | Drug: Iopromide<br>* Low-osmolar contrast medium (Iopromide) will be administered during PCI<br>* Other names: Ultravist®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast media, angiography, percutaneous coronary intervention