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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)

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ClinicalTrials.gov Identifier: NCT00827788
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : November 16, 2010
Sponsor:
Collaborators:
Ospedale Le Scotte
Ospedale della Misericordia - Grosseto
Information provided by:
Ospedale San Donato

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.

Condition or disease Intervention/treatment Phase
Contrast Induced Nephropathy Acute Myocardial Infarction Drug: Iodixanol Drug: Iopromide Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
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.
Study Start Date : December 2008
Actual Primary Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
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®



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 23, 2009    Key Record Dates
Last Update Posted: November 16, 2010
Last Verified: September 2009

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases