Clinical trial NCT00149591: The Viability-Guided Angioplasty After Acute Myocardial Infarction-Trial (The VIAMI-Trial)
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Coronary Artery Disease
Keywords: Myocardial infarction
Viability
Coronary angioplasty
Prevention
Prognosis
Lead sponsor: Netherlands Heart Foundation
Sponsor class: OTHER
Collaborators: name: The Interuniversity Cardiology Institute of the Netherlands
name: Eli Lilly and Company
name: Boehringer Ingelheim
name: Bristol-Myers Squibb
First posted: 2005-09-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Death
measure: Recurrent myocardial infarction
measure: Unstable angina for which hospital admission required
measure: Analysis at 30 days, 6 months and 1 year
Secondary outcomes:
measure: Left ventricular function (Echocardiography)
measure: Incidence of heart failure (NYHA)
measure: Angina pectoris class (CCS)
measure: Need for revascularization procedures
measure: Analysis at 3 and 6 months and after 1 year
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medical Center Alkmaar (MCA)
city: Amsterdam
country: Netherlands
facility: Sint LucasAndreas Hospital
city: Amsterdam
country: Netherlands
facility: VU University medical center
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis
city: Heerlen
country: Netherlands
facility: Atrium Medical Center Heerlen
city: Hilversum
country: Netherlands
facility: Hospital Hilversum
city: Leiderdorp
country: Netherlands
facility: Rijnland Hospital
city: Nijmegen
country: Netherlands
facility: University Medical Center St. Radboud
city: Purmerend
country: Netherlands
facility: Waterland Hospital
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Zaandam
country: Netherlands
facility: Zaans Medical Center "De Heel"
Study officials:
affiliation: VU University medical center, Amsterdam, The Netherlands
name: Gerrit Veen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VU University medical center, Amsterdam, The Netherlands
name: Cees A Visser, MD, PhD
role: STUDY_CHAIR
affiliation: Amsterdam UMC, location VUmc
name: Frans C Visser, MD, PhD
role: STUDY_DIRECTOR
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citation: 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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