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Thrombectomy in Acute Myocardial Infarction (TAMI)

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Thrombectomy
Primary angioplasty
Sponsored by
National Institute of Cardiology, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring myocardial infarction, thrombectomy, salvage index

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institute of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

T

P

Arm Description

Patients treated with thrombectomy: T

Patients treated with standard PCI with stent implantation

Outcomes

Primary Outcome Measures

Myocardial salvage index assessed with SPECT MIBI.

Secondary Outcome Measures

In hospital mortality
ST segment resolution after PCI;
CK-MB AUC
Corrected TIMI frame count

Full Information

First Posted
May 7, 2008
Last Updated
January 28, 2009
Sponsor
National Institute of Cardiology, Warsaw, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT00675480
Brief Title
Thrombectomy in Acute Myocardial Infarction
Acronym
TAMI
Official Title
Aspiration Thrombectomy as an Adjunctive Therapy to Primary Angioplasty in Patients With ST Segment Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Cardiology, Warsaw, Poland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
myocardial infarction, thrombectomy, salvage index

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
T
Arm Type
Experimental
Arm Description
Patients treated with thrombectomy: T
Arm Title
P
Arm Type
Active Comparator
Arm Description
Patients treated with standard PCI with stent implantation
Intervention Type
Procedure
Intervention Name(s)
Thrombectomy
Other Intervention Name(s)
Rescue (Boston Scientific), Diver (Invatec)
Intervention Description
Aspiration Thrombectomy prior to stent implantation in patients with ST segment elevation myocardial infarction
Intervention Type
Procedure
Intervention Name(s)
Primary angioplasty
Other Intervention Name(s)
Bare metal stent implanted during primary angioplasty
Intervention Description
Standard primary angioplasty with stent implantation
Primary Outcome Measure Information:
Title
Myocardial salvage index assessed with SPECT MIBI.
Time Frame
5-8 days
Secondary Outcome Measure Information:
Title
In hospital mortality
Time Frame
in hospital, before discharge
Title
ST segment resolution after PCI;
Time Frame
90 minutes
Title
CK-MB AUC
Time Frame
72 hours
Title
Corrected TIMI frame count
Time Frame
immediately post PCI

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Ciszewski, MD, PhD
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Cardiology
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21234920
Citation
Ciszewski M, Pregowski J, Teresinska A, Karcz M, Kalinczuk L, Pracon R, Witkowski A, Ruzyllo W. Aspiration coronary thrombectomy for acute myocardial infarction increases myocardial salvage: single center randomized study. Catheter Cardiovasc Interv. 2011 Oct 1;78(4):523-31. doi: 10.1002/ccd.22933. Epub 2011 Jun 6.
Results Reference
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Thrombectomy in Acute Myocardial Infarction

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