Thrombectomy in Acute Myocardial Infarction (TAMI)

National Institute of Cardiology, Warsaw, Poland

Status and phase: Completed; Phase 3

Conditions: Acute Myocardial Infarction

Treatments: Procedure: Thrombectomy; Procedure: Primary angioplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT00675480

2PO5C00527

Details and patient eligibility

About

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

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. First acute myocardial infarction with ST segment elevation within 12 hours from pain onset
2. Culprit lesion in left anterior descending or right coronary artery.
3. Coronary flow assessed in TIMI scale ≤ 2
4. Presence of total coronary occlusion or angiographically visible thrombus in the culprit vessel
5. Patient signed informed consent

Exclusion criteria

1. Cardiogenic shock.
2. Culprit lesion in left circumflex coronary artery.
3. Status post coronary artery by-pass grafting
4. Previous myocardial infarction
5. Status post percutaneous coronary intervention.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

T

Experimental group

Description:

Patients treated with thrombectomy: T

Treatment:

Procedure: Thrombectomy

P

Active Comparator group

Description:

Patients treated with standard PCI with stent implantation

Treatment:

Procedure: Primary angioplasty