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.
Sponsor:
Collaborators:
Ospedale Le Scotte
Ospedale della Misericordia - Grosseto
Information provided by:
Ospedale San Donato
ClinicalTrials.gov Identifier:
NCT00827788
First received: January 22, 2009
Last updated: November 15, 2010
Last verified: September 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • TIMI grade flow [ Time Frame: before and after primary PCI ] [ Designated as safety issue: No ]
  • Corrected TFC (TIMI frame count) [ Time Frame: after primary PCI ] [ Designated as safety issue: No ]
  • TMPG (TIMI Myocardial Perfusion Grade) [ Time Frame: after PCI ] [ Designated as safety issue: No ]
  • LFR slope (load to function slope) [ Time Frame: after primary PCI ] [ Designated as safety issue: Yes ]
  • MACE [ Time Frame: 1, 6, 12 months ] [ Designated as safety issue: No ]
  • absolute increase in serum Creatinine [ Time Frame: days 1, 2, 3, and at discharge ] [ Designated as safety issue: Yes ]
  • relative increase in serum creatinine of 50% or more [ Time Frame: days 1, 2, 3, and at discharge ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827788

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

No publications provided by Ospedale San Donato

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cardiovascular Department USL 8(Leonardo Bolognese MD), Ospedale SanDonato
ClinicalTrials.gov 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
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Infarction
Kidney Diseases
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Urologic Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Contrast Media
Iodixanol
Iopromide
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014