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

This study has been completed.
Ospedale Le Scotte
Ospedale della Misericordia - Grosseto
Information provided by:
Ospedale San Donato Identifier:
First received: January 22, 2009
Last updated: November 15, 2010
Last verified: September 2009
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.

Condition Intervention Phase
Contrast Induced Nephropathy Acute Myocardial Infarction Drug: Iodixanol Drug: Iopromide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Contrast Media and Nephrotoxicity Following Coronary Revascularization by Primary Angioplasty for Acute Myocardial Infarction. The CONTRAST-AMI Study.

Resource links provided by NLM:

Further study details as provided by Ospedale San Donato:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • TIMI grade flow [ Time Frame: before and after primary PCI ]
  • Corrected TFC (TIMI frame count) [ Time Frame: after primary PCI ]
  • TMPG (TIMI Myocardial Perfusion Grade) [ Time Frame: after PCI ]
  • LFR slope (load to function slope) [ Time Frame: after primary PCI ]
  • MACE [ Time Frame: 1, 6, 12 months ]
  • absolute increase in serum Creatinine [ Time Frame: days 1, 2, 3, and at discharge ]
  • relative increase in serum creatinine of 50% or more [ Time Frame: days 1, 2, 3, and at discharge ]

Estimated Enrollment: 432
Study Start Date: December 2008
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: iodixanol
Iso-osmolar contrast medium (Iodixanol) will be administered during PCI
Drug: Iodixanol
Iso-osmolar contrast medium (Iodixanol) will be administered during PCI
Other Name: Visipaque®
Active Comparator: iopromide
Low-osmolar contrast medium (Iopromide) will be administered during PCI
Drug: Iopromide
Low-osmolar contrast medium (Iopromide) will be administered during PCI
Other Name: Ultravist®

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00827788

Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy, 52100
Sponsors and Collaborators
Ospedale San Donato
Ospedale Le Scotte
Ospedale della Misericordia - Grosseto
Principal Investigator: Leonardo Bolognese, MD, FESC Ospedale SanDonato
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cardiovascular Department USL 8(Leonardo Bolognese MD), Ospedale SanDonato Identifier: NCT00827788     History of Changes
Other Study ID Numbers: Arezzo001
EUDRACT 2008-008491-13
Study First Received: January 22, 2009
Last Updated: November 15, 2010

Keywords provided by Ospedale San Donato:
contrast media
percutaneous coronary intervention

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on September 21, 2017