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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00149591
Recruitment Status : Unknown
Verified September 2006 by Netherlands Heart Foundation.
Recruitment status was:  Active, not recruiting
First Posted : September 8, 2005
Last Update Posted : September 5, 2008
The Interuniversity Cardiology Institute of the Netherlands
Eli Lilly and Company
Boehringer Ingelheim
Bristol-Myers Squibb
Information provided by:
Netherlands Heart Foundation

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 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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Coronary Artery Disease Procedure: coronary balloon-angioplasty with stenting Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : April 2001
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Death
  2. Recurrent myocardial infarction
  3. Unstable angina for which hospital admission required
  4. Analysis at 30 days, 6 months and 1 year

Secondary Outcome Measures :
  1. Left ventricular function (Echocardiography)
  2. Incidence of heart failure (NYHA)
  3. Angina pectoris class (CCS)
  4. Need for revascularization procedures
  5. Analysis at 3 and 6 months and after 1 year

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00149591

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Medical Center Alkmaar (MCA)
Alkmaar, Netherlands, 1815 JD
Sint LucasAndreas Hospital
Amsterdam, Netherlands, 1058 NR
VU University medical center
Amsterdam, Netherlands, 1081 HV
Catharina Hospital
Eindhoven, Netherlands, 5623 EJ
Kennemer Gasthuis
Haarlem, Netherlands, 2000 AK
Atrium Medical Center Heerlen
Heerlen, Netherlands, 6401 CX
Hospital Hilversum
Hilversum, Netherlands, 1213 XZ
Rijnland Hospital
Leiderdorp, Netherlands, 2350 CC
University Medical Center St. Radboud
Nijmegen, Netherlands, 6525 GA
Waterland Hospital
Purmerend, Netherlands, 1441 RN
Utrecht, Netherlands, 3582 KE
Zaans Medical Center "De Heel"
Zaandam, Netherlands, 1500 EE
Sponsors and Collaborators
Netherlands Heart Foundation
The Interuniversity Cardiology Institute of the Netherlands
Eli Lilly and Company
Boehringer Ingelheim
Bristol-Myers Squibb
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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
Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00149591    
Other Study ID Numbers: 2000B026
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: September 5, 2008
Last Verified: September 2006
Keywords provided by Netherlands Heart Foundation:
Myocardial infarction
Coronary angioplasty
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases