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

San Donato Group (GSD)

Status and phase: Completed; Phase 4

Conditions: Contrast Induced Nephropathy; Acute Myocardial Infarction

Treatments: Drug: Iopromide; Drug: Iodixanol

Study type: Interventional

Funder types: Other

Identifiers

NCT00827788

Arezzo001

EUDRACT 2008-008491-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 432 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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432 participants in 2 patient groups

iodixanol

Active Comparator group

Description:

Iso-osmolar contrast medium (Iodixanol) will be administered during PCI

Treatment:

Drug: Iodixanol

iopromide

Active Comparator group

Description:

Low-osmolar contrast medium (Iopromide) will be administered during PCI

Treatment:

Drug: Iopromide