Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI)
NCT ID: NCT00827788
Last Updated: 2010-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
432 participants
INTERVENTIONAL
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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iodixanol
Iso-osmolar contrast medium (Iodixanol) will be administered during PCI
Iodixanol
Iso-osmolar contrast medium (Iodixanol) will be administered during PCI
iopromide
Low-osmolar contrast medium (Iopromide) will be administered during PCI
Iopromide
Low-osmolar contrast medium (Iopromide) will be administered during PCI
Interventions
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Iodixanol
Iso-osmolar contrast medium (Iodixanol) will be administered during PCI
Iopromide
Low-osmolar contrast medium (Iopromide) will be administered during PCI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ospedale Le Scotte
OTHER
Ospedale della Misericordia - Grosseto
UNKNOWN
Ospedale San Donato
OTHER
Responsible Party
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Ospedale SanDonato
Principal Investigators
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Leonardo Bolognese, MD, FESC
Role: PRINCIPAL_INVESTIGATOR
Ospedale SanDonato
Locations
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Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy
Countries
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References
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Bolognese L, Falsini G, Grotti S, Limbruno U, Liistro F, Carrera A, Angioli P, Picchi A, Ducci K, Pierli C. The contrast media and nephrotoxicity following coronary revascularization by primary angioplasty for acute myocardial infarction study: design and rationale of the CONTRAST-AMI study. J Cardiovasc Med (Hagerstown). 2010 Mar;11(3):199-206. doi: 10.2459/JCM.0b013e32833186a4.
Other Identifiers
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EUDRACT 2008-008491-13
Identifier Type: -
Identifier Source: secondary_id
Arezzo001
Identifier Type: -
Identifier Source: org_study_id