Back to resultsComparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI) (CONTRAST-AMI)
Primary Purpose
Contrast Induced Nephropathy, Acute Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Iodixanol
Iopromide
Sponsored by
About this trial
This is an interventional prevention trial for Contrast Induced Nephropathy focused on measuring contrast media, angiography, percutaneous coronary intervention
Eligibility 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
Sites / Locations
- Cardiovascular Department, Ospedale S.Donato
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
iodixanol
iopromide
Arm Description
Iso-osmolar contrast medium (Iodixanol) will be administered during PCI
Low-osmolar contrast medium (Iopromide) will be administered during PCI
Outcomes
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
Secondary Outcome Measures
TIMI grade flow
Corrected TFC (TIMI frame count)
TMPG (TIMI Myocardial Perfusion Grade)
LFR slope (load to function slope)
MACE
absolute increase in serum Creatinine
relative increase in serum creatinine of 50% or more
Full Information
NCT ID
NCT00827788
First Posted
January 22, 2009
Last Updated
November 15, 2010
Sponsor
Ospedale San Donato
Collaborators
Ospedale Le Scotte, Ospedale della Misericordia - Grosseto
1. Study Identification
Unique Protocol Identification Number
NCT00827788
Brief Title
Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI)
Acronym
CONTRAST-AMI
Official Title
The Contrast Media and Nephrotoxicity Following Coronary Revascularization by Primary Angioplasty for Acute Myocardial Infarction. The CONTRAST-AMI Study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ospedale San Donato
Collaborators
Ospedale Le Scotte, Ospedale della Misericordia - Grosseto
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy, Acute Myocardial Infarction
Keywords
contrast media, angiography, percutaneous coronary intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
432 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iodixanol
Arm Type
Active Comparator
Arm Description
Iso-osmolar contrast medium (Iodixanol) will be administered during PCI
Arm Title
iopromide
Arm Type
Active Comparator
Arm Description
Low-osmolar contrast medium (Iopromide) will be administered during PCI
Intervention Type
Drug
Intervention Name(s)
Iodixanol
Other Intervention Name(s)
Visipaque®
Intervention Description
Iso-osmolar contrast medium (Iodixanol) will be administered during PCI
Intervention Type
Drug
Intervention Name(s)
Iopromide
Other Intervention Name(s)
Ultravist®
Intervention Description
Low-osmolar contrast medium (Iopromide) will be administered during PCI
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
TIMI grade flow
Time Frame
before and after primary PCI
Title
Corrected TFC (TIMI frame count)
Time Frame
after primary PCI
Title
TMPG (TIMI Myocardial Perfusion Grade)
Time Frame
after PCI
Title
LFR slope (load to function slope)
Time Frame
after primary PCI
Title
MACE
Time Frame
1, 6, 12 months
Title
absolute increase in serum Creatinine
Time Frame
days 1, 2, 3, and at discharge
Title
relative increase in serum creatinine of 50% or more
Time Frame
days 1, 2, 3, and at discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Bolognese, MD, FESC
Organizational Affiliation
Ospedale SanDonato
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Department, Ospedale S.Donato
City
Arezzo
State/Province
AR
ZIP/Postal Code
52100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
19829124
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI)
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