Physiologic Assessment of Thrombus Aspiration in Acute ST-segment Elevation Myocardial Infarction Patients

Study Overview
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Brief Summary
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The Physiologic Assessment of Thrombus Aspiration in ST-segment Elevation Myocardial Infarction (PATA-STEMI) trial is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first ST-segment elevation myocardial infarction (STEMI). Patients are, before coronary angiography, randomly assigned to thrombus aspiration using 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to conventional primary percutaneous coronary intervention (PCI). The primary endpoint is index of microcirculatory resistance (IMR), measured in infarct-related artery, in thrombus aspiration compared to conventional PCI group.

Detailed Description
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Background and Objective Routine thrombus aspiration is superior to conventional primary PCI in terms of improved myocardial perfusion in STEMI patients. However, myocardial perfusion after thrombus aspiration has not been evaluated by a quantitative, invasive method. Investigators intend to determine whether thrombus aspiration of the infarct-related artery increases myocardial perfusion, as measured by IMR, compared to conventional primary PCI. Study design PATA-STEMI is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first STEMI. Patients are randomly assigned, before coronary angiography, to thrombus aspiration using the 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to conventional primary PCI. The IMR will be determined in infarct-related artery and non-infarct-related arteries without critical stenosis to measure microcirculatory resistance. The primary endpoint is defined as IMR in infarct-related artery in thrombus aspiration compared to conventional PCI group. Secondary end points are myocardial perfusion grade and resolution of ST-segment elevation, infarct size and left ventricle remodeling, as assessed by echocardiographic indices. Transthoracic echocardiography will be conducted within 24 hours and at 4 months after the primary PCI. Implications: If manual thrombus aspiration reduces microcirculatory resistance, indicating improved myocardial perfusion, as compared to conventional PCI, it might become the preferred strategy in patients with STEMI.

Official Title
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The Randomized Physiologic Assessment of Thrombus Aspiration in Patients With Acute ST-segment Elevation Myocardial Infarction Trial

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Device: Eliminate aspiration catheter
* Procedure: Conventional primary angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consecutive patients with STEMI chest pain onset ≤12h, or >12 h with persistent ST-segment elevation hemodynamically stable patients Exclusion Criteria: patients without diagnosis of STEMI (pericarditis, for example) no written informed consent obtained prior Q or non-Q MI prior resuscitation prior thrombolysis prior surgical myocardial revascularisation life expectancy <6 months periprocedural death

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 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 |
| --- | --- |
| Experimental: Eliminate<br>Eliminate aspiration catheter | Device: Eliminate aspiration catheter<br>* Eliminate aspiration catheter<br>|
| Active Comparator: Conventional primary angioplasty<br>Patients treated with conventional primary angioplasty | Procedure: Conventional primary angioplasty<br>* Primary angioplasty without thrombus aspiration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IMR (mmHg seconds) in thrombus aspiration compared to conventional PCI group | IMR will be measured after final balloon inflation or stent implantation, an expected average of 45 minutes after sheath insertion | At the end of the primary PCI , an expected average of 45 minutes after sheath insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of ST-segment elevation | ST-segment resolution ≥70% at 60 minutes after guiding catheter removal | at 60 minutes after guiding catheter removal | 
| myocardial blush grade (0-3) | myocardial blush grade will be assessed after IMR measurements, following the final balloon inflation or stent implantation, an expected average of 55 minutes after sheath insertion | at final angiogram, an expected average of 55 minutes after sheath insertion | 
| infarct size assessed by peak enzyme release (Troponin, creatine kinase MB (CK-MB)) | infarct size will be determined based on peak enzyme release (Troponin, CK-MB) during in-hospital stay, an expected average of 5 days | in hospital course after primary PCI, an expected average of 5 days | 
| indices of left ventricle remodeling on Echocardiography | left ventricle remodeling will be assessed on Echocardiography within 24 hours and at 4 months after primary PCI | within 24 hours and at 4 months after primary PCI | 
| infarct size determined by SPECT | infarct size will be determined by SPECT within 7-14 days and at 4 months after primary PCI | within 7-14 days and at 4 months after primary PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute myocardial infarction, Manual thrombus aspiration, Coronary physiology