Acute ST Elevation Myocardial Infarction Clinical Trial
Official title:
INtra-Vascular Ultrasound Study of Export Thrombectomy in ST Elevation Myocardial Infarction Myocardial Infarction
To use IVUS to assess (1) culprit plaque morphology and thrombus burden in patients with ST-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration catheter in 40 patients during primary PCI.
Primary PCI has become the preferred therapy for ST-elevation acute myocardial infarction.
The TAPAS trial data suggests that widespread adoption of manual thrombus aspiration may
improve clinical outcomes for patients undergoing primary PCI.
Little data exists on the degree to which thrombus is removed during thrombectomy and how
much thrombus remains with the potential for distal embolisation during stent deployment.
The mechanism of lumen enlargement after thrombus aspiration is also unknown. Since
angiography only provides an outline image of the vascular lumen, such questions cannot be
adequately addressed by this modality alone.
The aim of this study is to use IVUS to assess (1) culprit plaque morphology and thrombus
burden in patients with ST-elevation myocardial infarction; (2) the efficacy of thrombus
removal with an aspiration catheter during primary PCI.
Hypotheses In this study we will assess 40 patients with STEMI. Primary PCI will be
performed according to our hospital standard working protocol with thrombus aspiration and
balloon dilatation of the culprit lesion if necessary prior to stent deployment. IVUS
imaging will be undertaken prior to, and following, passage of the aspirations catheter to
assess (1) initial and (2) residual thrombus volume. A third and final IVUS imaging run will
be performed after stenting of the culprit lesion. IVUS analysis will be performed off-line
to assess the lumen enlargement and volume of residual thrombus at each stage. All studies
will be undertaken with the approval of the local Clinical Research Ethics.
Aspirated material will be collected and analyzed. Clinical markers such as Troponin release
and left ventricular function will be assessed.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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