Coronary Artery Disease Clinical 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.
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.
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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