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OpenTrials
Completed

NCT Number: NCT00675480

Thrombectomy in Acute Myocardial Infarction

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

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Key information

Conditions

Acute Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Cardiology

Warsaw, 04-628, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thrombectomy

Procedure

Aspiration Thrombectomy prior to stent implantation in patients with ST segment elevation myocardial infarction

Other names: Rescue (Boston Scientific), Diver (Invatec)

Primary angioplasty

Procedure

Standard primary angioplasty with stent implantation

Other names: Bare metal stent implanted during primary angioplasty

Primary outcomes

  1. Myocardial salvage index assessed with SPECT MIBI.

    Time frame: 5-8 days

Secondary outcomes

  1. In hospital mortality

    Time frame: in hospital, before discharge

  2. ST segment resolution after PCI;

    Time frame: 90 minutes

  3. CK-MB AUC

    Time frame: 72 hours

  4. Corrected TIMI frame count

    Time frame: immediately post PCI

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Warsaw, Poland

Other

Registry information

Official study title

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

Acronym: TAMI

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
May 9, 2008
Registry last updated
Jan 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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