Status:

UNKNOWN

The Viability-Guided Angioplasty After Acute Myocardial Infarction-Trial (The VIAMI-Trial)

Lead Sponsor:

Netherlands Heart Foundation

Collaborating Sponsors:

The Interuniversity Cardiology Institute of the Netherlands

Eli Lilly and Company

Conditions:

Myocardial Infarction

Coronary Artery Disease

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

The VIAMI-trial investigates the effects of balloon angioplasty with stenting of the infarct-vessel in the early phase after acute myocardial infarction. The study concerns patients who have residual ...

Detailed Description

Earlier studies have shown that routine angioplasty of the infarct-related coronary artery soon after thrombolysis for acute myocardial infarction did not result in a clinical benefit. This finding em...

Eligibility Criteria

Inclusion

  • Admission within 6 hours of pain onset and EKG with ≥ 1 mm ST-segment elevation in two or more standard leads or ≥ 2 mm ST-elevation in two contiguous chest leads, indicative for transmural ischemia, with or without the development of new Q-waves, with myocardial necrosis proven by enzyme rise (total CPK ≥ 2x the upper normal limit).
  • Patient history compatible with subacute myocardial infarction ( ≥ 6 hours), with at least signs of myocardial necrosis on the EKG (Q-waves) and a significantly increased serum level of cardiac-specific enzymes.
  • Age between 18 and 80 years.
  • Viability testing performed prior to coronary angiography.
  • No clinical indication for an invasive procedure to be performed before viability testing

Exclusion

  • No informed consent obtained
  • Unreliable follow-up
  • Viability testing technically not possible
  • Contra-indications for dobutamine echocardiography (heart failure, arrhythmia)
  • Contra-indications for coronary angiography, such as severe diabetic nephropathy or know contrast-allergy
  • Known hypersensitivity for abciximab
  • Serious, life-threatening non-cardiac illness

Key Trial Info

Start Date :

April 1 2001

Trial Type :

INTERVENTIONAL

End Date :

January 1 2007

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT00149591

Start Date

April 1 2001

End Date

January 1 2007

Last Update

September 5 2008

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Medical Center Alkmaar (MCA)

Alkmaar, Netherlands, 1815 JD

2

Sint LucasAndreas Hospital

Amsterdam, Netherlands, 1058 NR

3

VU University medical center

Amsterdam, Netherlands, 1081 HV

4

Catharina Hospital

Eindhoven, Netherlands, 5623 EJ