Assessment of Lumen Expansion After Thrombus Extraction in Primary Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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INtra-Vascular Ultrasound Study of Export Thrombectomy in ST Elevation Myocardial Infarction Myocardial Infarction

Conditions
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Acute ST Elevation Myocardial Infarction

Intervention / Treatment
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* Device: Thrombus aspiration (Intravascular Ultrasound catheter (Boston))


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients 18-75 years old with myocardial infarction with ST-segment elevation symptoms of myocardial ischemia lasting more than 30 minutes onset of symptoms within 12 hours of hospital presentation ST-segment elevation of more than 0.1 mV in two or more leads on the ECG Exclusion Criteria: inability to obtain informed consent use of fibrinolytic drug within 12 hours of presentation comorbidity with anticipated life expectancy of < 6 months cardiogenic shock on presentation major bleeding diathesis history of aspirin and clopidogrel intolerance critical left main stem lesions severe calcfic disease precluding safe passage of the imaging catheter culprit lesion within saphenous vein grafts -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Only one arm<br>All patients will receive the same treatment, i.e. there is no randomization. There is therefore only one arm, all patients will by treated as per standard practice with thrombus aspiration and stenting as required, the lumen size of the vessel will be assessed with intravascular ultrasound at baseline, after thrombus aspiration and after stenting. | Device: Thrombus aspiration (Intravascular Ultrasound catheter (Boston))<br>* There is a single arm in the study where all patients are undergoing primary percutaneous coronary intervention for an acute myocardial infarction. All patients will have an Intravascular Ultrasound three times: At baseline After thrombus aspiration with a thrombus extraction catheter After stent deployment We are however assessing the physiological response of patients having an acute myocardial infarction and this is not a test of the devices as such.<br>* Other names: Intravascular Ultrasound catheter (Boston);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary artery lumen expansion after thrombus aspiration in primary percutaneous intervention. | Degree of thrombus extraction can be visualised immediately by intravascular ultrasound (IVUS) but detailed analysis will be carried out off-line and by histopathology of aspirated material within 4 months. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute MI, Primary percutaneous coronary intervention, thrombus aspiration, IVUS