Thrombectomy in Acute Myocardial Infarction

Study Overview
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Brief Summary
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The purpose of the study is to determine whether thrombus removal with aspiration thrombectomy for acute myocardial infarction reduces the infarct size.

Detailed Description
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Acute myocardial infarction is caused by an abrupt occlusion of coronary vessel or severe reduction of coronary flow. It has been shown that the reperfusion therapy significantly improves the clinical outcome. Currently the optimal strategy is the primary angioplasty with stent implantation. The treatment is recommended by AHA/ACC and ESC if can be performed within 90 minutes from the first medical contact. However there is still a certain percentage of procedure failure. To further improve the outcome new techniques and devices are tested . Aspiration thrombectomy may facilitate the reperfusion by reducing thrombus burden. The aim of the study is to assess if adjunctive thrombectomy may improve clinical outcome in patients with an acute ST segment elevation myocardial infarction.

Official Title
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Aspiration Thrombectomy as an Adjunctive Therapy to Primary Angioplasty in Patients With ST Segment Elevation Myocardial Infarction

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Procedure: Thrombectomy
* Procedure: Primary angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First acute myocardial infarction with ST segment elevation within 12 hours from pain onset Culprit lesion in left anterior descending or right coronary artery. Coronary flow assessed in TIMI scale ≤ 2 Presence of total coronary occlusion or angiographically visible thrombus in the culprit vessel Patient signed informed consent Exclusion Criteria: Cardiogenic shock. Culprit lesion in left circumflex coronary artery. Status post coronary artery by-pass grafting Previous myocardial infarction Status post percutaneous coronary intervention.
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: T<br>Patients treated with thrombectomy: T | Procedure: Thrombectomy<br>* Aspiration Thrombectomy prior to stent implantation in patients with ST segment elevation myocardial infarction<br>* Other names: Diver (Invatec);|
| Active Comparator: P<br>Patients treated with standard PCI with stent implantation | Procedure: Primary angioplasty<br>* Standard primary angioplasty with stent implantation<br>* Other names: Bare metal stent implanted during primary angioplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial salvage index assessed with SPECT MIBI. |  | 5-8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In hospital mortality |  | in hospital, before discharge | 
| ST segment resolution after PCI; |  | 90 minutes | 
| CK-MB AUC |  | 72 hours | 
| Corrected TIMI frame count |  | immediately post PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, thrombectomy, salvage index