Clinical trial NCT00827788: Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI)
Official title: The Contrast Media and Nephrotoxicity Following Coronary Revascularization by Primary Angioplasty for Acute Myocardial Infarction. The CONTRAST-AMI Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contrast Induced Nephropathy
Acute Myocardial Infarction
Keywords: contrast media
angiography
percutaneous coronary intervention
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
Collaborators: name: Ospedale Le Scotte
name: Ospedale della Misericordia - Grosseto
First posted: 2009-01-23
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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
timeFrame: days 1, 2, 3, and at discharge
Secondary outcomes:
measure: TIMI grade flow
timeFrame: before and after primary PCI
measure: Corrected TFC (TIMI frame count)
timeFrame: after primary PCI
measure: TMPG (TIMI Myocardial Perfusion Grade)
timeFrame: after PCI
measure: LFR slope (load to function slope)
timeFrame: after primary PCI
measure: MACE
timeFrame: 1, 6, 12 months
measure: absolute increase in serum Creatinine
timeFrame: days 1, 2, 3, and at discharge
measure: relative increase in serum creatinine of 50% or more
timeFrame: days 1, 2, 3, and at discharge
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Cardiovascular Department, Ospedale S.Donato
state: AR
Study officials:
affiliation: Ospedale SanDonato
name: Leonardo Bolognese, MD, FESC
role: PRINCIPAL_INVESTIGATOR
References:
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.