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Completed

NCT Number: NCT00827788

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iodixanol

Drug

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

Other names: Visipaque®

Iopromide

Drug

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

Other names: Ultravist®

Primary outcomes

  1. 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

  1. TIMI grade flow

    Time frame: before and after primary PCI

  2. Corrected TFC (TIMI frame count)

    Time frame: after primary PCI

  3. TMPG (TIMI Myocardial Perfusion Grade)

    Time frame: after PCI

  4. LFR slope (load to function slope)

    Time frame: after primary PCI

  5. MACE

    Time frame: 1, 6, 12 months

  6. absolute increase in serum Creatinine

    Time frame: days 1, 2, 3, and at discharge

  7. relative increase in serum creatinine of 50% or more

    Time frame: days 1, 2, 3, and at discharge

Sponsors and collaborators

Lead sponsor

Ospedale San Donato

Other

Collaborators

  • Ospedale Le Scotte
  • Ospedale della Misericordia - Grosseto

Registry information

Official study title

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

Acronym: CONTRAST-AMI

Important dates

Study start
2008
Primary completion
2010
First posted
Jan 23, 2009
Registry last updated
Nov 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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