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

November 15, 2010 updated by: Ospedale San Donato

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

432

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • AR
      • Arezzo, AR, Italy, 52100
        • Cardiovascular Department, Ospedale S.Donato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
days 1, 2, 3, and at discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
TIMI grade flow
Time Frame: before and after primary PCI
before and after primary PCI
Corrected TFC (TIMI frame count)
Time Frame: after primary PCI
after primary PCI
TMPG (TIMI Myocardial Perfusion Grade)
Time Frame: after PCI
after PCI
LFR slope (load to function slope)
Time Frame: after primary PCI
after primary PCI
MACE
Time Frame: 1, 6, 12 months
1, 6, 12 months
absolute increase in serum Creatinine
Time Frame: days 1, 2, 3, and at discharge
days 1, 2, 3, and at discharge
relative increase in serum creatinine of 50% or more
Time Frame: days 1, 2, 3, and at discharge
days 1, 2, 3, and at discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Donato

Collaborators

Ospedale Le Scotte
Ospedale della Misericordia - Grosseto

Investigators

  • Principal Investigator: Leonardo Bolognese, MD, FESC, Ospedale SanDonato

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

January 22, 2009

First Posted (Estimate)

January 23, 2009

Study Record Updates

Last Update Posted (Estimate)

November 16, 2010

Last Update Submitted That Met QC Criteria

November 15, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arezzo001
  • EUDRACT 2008-008491-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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