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

Sponsor
Ospedale San Donato (Other)
Overall Status
Completed
CT.gov ID
NCT00827788
Collaborator
Ospedale Le Scotte (Other), Ospedale della Misericordia - Grosseto (Other)
432
Enrollment
1
Location
2
Arms

Study Details

Study Description

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
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 Design

Study Type:
Interventional
Anticipated 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 :
Dec 1, 2008
Actual Primary Completion Date :
Apr 1, 2010

Arms and Interventions

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 Names:
  • 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 Names:
  • Ultravist®

    		•

    Outcome Measures

    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 [days 1, 2, 3, and at discharge]

    Secondary Outcome Measures

    1. TIMI grade flow [before and after primary PCI]

    2. Corrected TFC (TIMI frame count) [after primary PCI]

    3. TMPG (TIMI Myocardial Perfusion Grade) [after PCI]

    4. LFR slope (load to function slope) [after primary PCI]

    5. MACE [1, 6, 12 months]

    6. absolute increase in serum Creatinine [days 1, 2, 3, and at discharge]

    7. relative increase in serum creatinine of 50% or more [days 1, 2, 3, and at discharge]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00827788
    Other Study ID Numbers:
    • Arezzo001
    • EUDRACT 2008-008491-13
    First Posted:
    Jan 23, 2009
    Last Update Posted:
    Nov 16, 2010
    Last Verified:
    Sep 1, 2009
    Keywords provided by , ,
    contrast media
    angiography
    percutaneous coronary intervention
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Nov 16, 2010