The Viability-Guided Angioplasty After Acute Myocardial Infarction-Trial (The VIAMI-Trial)
NCT ID: NCT00149591
Last Updated: 2008-09-05
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
300 participants
Study Classification
INTERVENTIONAL
Study Start Date
2001-04-30
Study Completion Date
2007-01-31
Brief Summary
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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.
Detailed Description
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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.
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.
Conditions
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Myocardial Infarction
Coronary Artery Disease
Keywords
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Myocardial infarction
Viability
Coronary angioplasty
Prevention
Prognosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Interventions
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coronary balloon-angioplasty with stenting
Intervention Type
PROCEDURE
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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The Interuniversity Cardiology Institute of the Netherlands
OTHER_GOV
Sponsor Role
collaborator
Eli Lilly and Company
INDUSTRY
Sponsor Role
collaborator
Boehringer Ingelheim
INDUSTRY
Sponsor Role
collaborator
Bristol-Myers Squibb
INDUSTRY
Sponsor Role
collaborator
Netherlands Heart Foundation
OTHER
Sponsor Role
lead
Principal Investigators
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Gerrit Veen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
VU University medical center, Amsterdam, The Netherlands
Cees A Visser, MD, PhD
Role: STUDY_CHAIR
VU University medical center, Amsterdam, The Netherlands
Frans C Visser, MD, PhD
Role: STUDY_DIRECTOR
Amsterdam UMC, location VUmc
Locations
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Medical Center Alkmaar (MCA)
Alkmaar, , Netherlands
Site Status
Sint LucasAndreas Hospital
Amsterdam, , Netherlands
Site Status
VU University medical center
Amsterdam, , Netherlands
Site Status
Catharina Hospital
Eindhoven, , Netherlands
Site Status
Kennemer Gasthuis
Haarlem, , Netherlands
Site Status
Atrium Medical Center Heerlen
Heerlen, , Netherlands
Site Status
Hospital Hilversum
Hilversum, , Netherlands
Site Status
Rijnland Hospital
Leiderdorp, , Netherlands
Site Status
University Medical Center St. Radboud
Nijmegen, , Netherlands
Site Status
Waterland Hospital
Purmerend, , Netherlands
Site Status
Diakonessenhuis
Utrecht, , Netherlands
Site Status
Zaans Medical Center "De Heel"
Zaandam, , Netherlands
Site Status
Countries
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Netherlands
References
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BACKGROUND
van Loon RB, Veen G, Kamp O, Baur LH, van Rossum AC. Left ventricular remodeling after acute myocardial infarction: the influence of viability and revascularization - an echocardiographic substudy of the VIAMI-trial. Trials. 2014 Aug 18;15:329. doi: 10.1186/1745-6215-15-329.
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DERIVED
van Loon RB, Veen G, Baur LH, Kamp O, Bronzwaer JG, Twisk JW, Verheugt FW, van Rossum AC. Improved clinical outcome after invasive management of patients with recent myocardial infarction and proven myocardial viability: primary results of a randomized controlled trial (VIAMI-trial). Trials. 2012 Jan 3;13:1. doi: 10.1186/1745-6215-13-1.
Reference Type
DERIVED
Related Links
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http://www.escardio.org/congresses/world_congress_cardiology_2006/congressreports/pages/709007_veen.aspx
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Other Identifiers
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H4S-UT-O017
Identifier Type: -
Identifier Source: secondary_id
2000B026
Identifier Type: -
Identifier Source: org_study_id