Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study

Study Overview
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Brief Summary
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In this trial, the investigators will evaluate the effect of thrombus aspiration followed by stent implantation in improving myocardial blush grade in patients with acute non-ST-elevation myocardial infarction compared to conventional percutaneous coronary intervention (PCI).

Detailed Description
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The Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) has shown that thrombus aspiration improves myocardial perfusion and clinical outcome compared to conventional primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction. Impaired myocardial perfusion due to spontaneous or angioplasty-induced embolization of atherothrombotic material also occurs in patients with Non-ST-elevation myocardial infarction (NSTEMI). The aim of this study is to determine whether thrombus aspiration before stent implantation will result in improved myocardial perfusion in patients with NSTEMI compared to conventional PCI. The study is a single-centre, prospective, randomised trial with blinded evaluation of endpoints. The planned inclusion is 540 patients with acute NSTEMI who are candidates for urgent PCI. If thrombus aspiration leads to significant improvement of myocardial perfusion in patients with acute NSTEMI it may become part of the standard interventional approach.

Official Title
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Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)

Conditions
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Non-ST-Elevation Myocardial Infarction

Intervention / Treatment
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* Procedure: Thrombus aspiration followed by stent implantation
* Procedure: conventional PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of acute NSTEMI defined by Chest pain suggestive for myocardial ischemia for at least 30 minutes, Time from onset of symptoms of less than 72 hours ECG with ST-segment shifts (depression of >0.1 mV in at least two contiguous leads or transient ST-segment elevation >0.1 mV in at least two contiguous leads for less than 30 minutes) and/or T-wave changes (inversion of >0.15 mV in at least two contiguous leads) Positive cardiac troponin T >0,01 μg/L. Clinical indication for urgent PCI of the ischemia-related target lesion as identified at coronary angiography Exclusion Criteria: Persistent ST-elevation of more than 0.1 mV in 2 or more leads Presence of cardiogenic shock Inability to obtain informed consent Known existence of a life-threatening disease with a life expectancy of less than 6 months

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional percutaneous coronary intervention<br> | Procedure: conventional PCI<br>* balloon angioplasty and/or stent implantation<br>|
| Experimental: Thrombus aspiration<br> | Procedure: Thrombus aspiration followed by stent implantation<br>* Export aspiration catheter 6F (Medtronics)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of myocardial blush grade 3 after PCI |  | During PCI procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary angiographic outcomes |  | During PCI procedure | 
| Histopathological outcomes of atherothrombotic material |  | After inclusion is stopped: mean 1 year (storage at -80 degrees Celcius) | 
| Enzymatic infarct size |  | During hospital stay | 
| Electrocardiographic outcomes |  | 30 to 60 minutes after PCI | 
| Clinical outcomes at 30 days and 1 year |  | 30 days till 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, percutaneous coronary intervention, thrombus aspiration