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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00827788

Acronym

CONTRAST-AMI

Enrollment

432

Registered

2009-01-23

Start date

2008-12-31

Completion date

Unknown

Last updated

2010-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast Induced Nephropathy, Acute Myocardial Infarction

Keywords

contrast media, angiography, percutaneous coronary intervention

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.

Interventions

DRUGIodixanol

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

DRUGIopromide

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026