NCT00827788

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
432

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Last Updated

November 16, 2010

Status Verified

September 1, 2009

Enrollment Period

1.3 years

First QC Date

January 22, 2009

Last Update Submit

November 15, 2010

Conditions

Contrast Induced NephropathyAcute Myocardial Infarction

Keywords

contrast mediaangiographypercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • TIMI grade flow

    before and after primary PCI

  • Corrected TFC (TIMI frame count)

    after primary PCI

  • TMPG (TIMI Myocardial Perfusion Grade)

    after PCI

  • LFR slope (load to function slope)

    after primary PCI

  • MACE

    1, 6, 12 months

  • +2 more secondary outcomes

Study Arms (2)

iodixanol

ACTIVE COMPARATOR

Iso-osmolar contrast medium (Iodixanol) will be administered during PCI

Drug: Iodixanol

iopromide

ACTIVE COMPARATOR

Low-osmolar contrast medium (Iopromide) will be administered during PCI

Drug: Iopromide

Interventions

IodixanolDRUG

Iso-osmolar contrast medium (Iodixanol) will be administered during PCI

Also known as: Visipaque®
iodixanol
IopromideDRUG

Low-osmolar contrast medium (Iopromide) will be administered during PCI

Also known as: Ultravist®
iopromide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 19829124DERIVED

MeSH Terms

Interventions

iodixanoliopromide

Study Officials

  • Leonardo Bolognese, MD, FESC

    Ospedale SanDonato

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 23, 2009

Study Start

December 1, 2008

Primary Completion

April 1, 2010

Last Updated

November 16, 2010

Record last verified: 2009-09

Locations

IT(1)