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

September 4, 2008 updated by: Netherlands Heart Foundation

Early and Long-Term Outcome of Elective Stenting of the Infarct-Related Artery in Patients With Viability in the Infarct-Area Early After Acute Myocardial Infarction. The VIAMI-Trial.

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 viable tissue in the infarct-area after being treated with thrombolysis. It is postulated that only patients with remaining viable tissue are at high-risk for recurrent infarction or anginal attacks and that stenting of the infarct-vessel will reduce this risk considerably.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 emphasizes the importance to select a subgroup of patients with a recent myocardial infarction, who will really benefit from angioplasty of the infarct-related artery.

Several studies have demonstrated that the presence of viability in the infarct-area early after acute myocardial infarction imposes an increased risk of new cardiac events like recurrent infarction, angina pectoris and need for coronary interventions. Therefore, it is postulated that only patients with viability in the infarct-area will benefit from angioplasty early after acute myocardial infarction.

In the VIAMI-trial patients who are admitted to the hospital with an acute myocardial infarction and who did not undergo immediate coronary angioplasty, will undergo viability testing by dobutamine-echocardiography within 3 days of admission. Patients with unequivocal signs of viability in the infarct-area will then be randomized to an invasive or a conservative treatment strategy. In the invasive strategy patients will undergo coronary angiography with the intention to perform balloon angioplasty with stenting of the infarct-related coronary artery, with concomitant use of the intravenous platelet inhibitor abciximab. In the conservative group patients will undergo coronary angiography and angioplasty only when new impending infarction or recurrent ischemia is present. In the invasive group balloon angioplasty will be performed as soon as possible after randomization. Patients without viability will not be randomized,but will participate as a control group.

Study Type

Interventional

Enrollment

300

Phase

  • Not Applicable

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

  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Medical Center Alkmaar (MCA)
      • Amsterdam, Netherlands, 1058 NR
        • Sint LucasAndreas Hospital
      • Amsterdam, Netherlands, 1081 HV
        • VU University Medical Center
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina hospital
      • Haarlem, Netherlands, 2000 AK
        • Kennemer Gasthuis
      • Heerlen, Netherlands, 6401 CX
        • Atrium medical center Heerlen
      • Hilversum, Netherlands, 1213 XZ
        • Hospital Hilversum
      • Leiderdorp, Netherlands, 2350 CC
        • Rijnland Hospital
      • Nijmegen, Netherlands, 6525 GA
        • University Medical Center St. Radboud
      • Purmerend, Netherlands, 1441 RN
        • Waterland Hospital
      • Utrecht, Netherlands, 3582 KE
        • Diakonessenhuis
      • Zaandam, Netherlands, 1500 EE
        • Zaans Medical Center "De Heel"

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

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: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Death
Recurrent myocardial infarction
Unstable angina for which hospital admission required
Analysis at 30 days, 6 months and 1 year

Secondary Outcome Measures

Outcome Measure
Left ventricular function (Echocardiography)
Incidence of heart failure (NYHA)
Angina pectoris class (CCS)
Need for revascularization procedures
Analysis at 3 and 6 months and after 1 year

Collaborators and Investigators

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

Sponsor

Netherlands Heart Foundation

Collaborators

Bristol-Myers Squibb
Eli Lilly and Company
Boehringer Ingelheim
The Interuniversity Cardiology Institute of the Netherlands

Investigators

  • Principal Investigator: Gerrit Veen, MD, PhD, VU University medical center, Amsterdam, The Netherlands
  • Study Chair: Cees A Visser, MD, PhD, VU University medical center, Amsterdam, The Netherlands
  • Study Director: Frans C Visser, MD, PhD, Amsterdam Umc, Location Vumc

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

Helpful Links

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

April 1, 2001

Study Completion

January 1, 2007

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

September 5, 2008

Last Update Submitted That Met QC Criteria

September 4, 2008

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000B026
  • H4S-UT-O017

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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