Thrombectomy in Acute Myocardial Infarction (TAMI)

January 28, 2009 updated by: Institute of Cardiology, Warsaw, Poland

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 04-628
        • Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T
Patients treated with thrombectomy: T
Procedure: Thrombectomy
Aspiration Thrombectomy prior to stent implantation in patients with ST segment elevation myocardial infarction
Other Names:
  • Rescue (Boston Scientific)
  • Diver (Invatec)
Active Comparator: P
Patients treated with standard PCI with stent implantation
Procedure: Primary angioplasty
Standard primary angioplasty with stent implantation
Other Names:
  • Bare metal stent implanted during primary angioplasty

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cardiology, Warsaw, Poland

Investigators

  • Principal Investigator: Michal Ciszewski, MD, PhD, Institute of Cardiology, Warsaw, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

May 8, 2008

First Posted (Estimate)

May 9, 2008

Study Record Updates

Last Update Posted (Estimate)

January 29, 2009

Last Update Submitted That Met QC Criteria

January 28, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2PO5C00527

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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