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

Acute Myocardial Infarction Clinical Trial

— CONTRAST-AMI  

Official title:

The Contrast Media and Nephrotoxicity Following Coronary Revascularization by Primary Angioplasty for Acute Myocardial Infarction. The CONTRAST-AMI Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827788
• Other study ID #: Arezzo001
• Secondary ID: EUDRACT 2008-008
• Status: Completed
• Phase: Phase 4
• First received: January 22, 2009
• Last updated: November 15, 2010
• Start date: December 2008

Study information

• Verified date: September 2009
• Source: Ospedale San Donato
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Contrast Induced Nephropathy
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Iodixanol
Iso-osmolar contrast medium (Iodixanol) will be administered during PCI
• Iopromide
Low-osmolar contrast medium (Iopromide) will be administered during PCI

Locations

Country	Name	City	State
Italy	Cardiovascular Department, Ospedale S.Donato	Arezzo	AR

Sponsors (3)

Lead Sponsor	Collaborator
Ospedale San Donato	Ospedale della Misericordia - Grosseto, Ospedale Le Scotte

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	TIMI grade flow		before and after primary PCI	No
Secondary	Corrected TFC (TIMI frame count)		after primary PCI	No
Secondary	TMPG (TIMI Myocardial Perfusion Grade)		after PCI	No
Secondary	LFR slope (load to function slope)		after primary PCI	Yes
Secondary	MACE		1, 6, 12 months	No
Secondary	absolute increase in serum Creatinine		days 1, 2, 3, and at discharge	Yes
Secondary	relative increase in serum creatinine of 50% or more		days 1, 2, 3, and at discharge	Yes