Thrombectomy in Acute Myocardial Infarction

NCT ID: NCT00675480

Last Updated: 2009-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2008-09-30

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.

Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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T

Patients treated with thrombectomy: T

Group Type EXPERIMENTAL

Thrombectomy

Intervention Type PROCEDURE

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

P

Patients treated with standard PCI with stent implantation

Group Type ACTIVE_COMPARATOR

Primary angioplasty

Intervention Type PROCEDURE

Standard primary angioplasty with stent implantation

Interventions

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Thrombectomy

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

Intervention Type PROCEDURE

Primary angioplasty

Standard primary angioplasty with stent implantation

Intervention Type PROCEDURE

Other Intervention Names

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Rescue (Boston Scientific) Diver (Invatec) Bare metal stent implanted during primary angioplasty

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role lead

Responsible Party

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Institute of Cardiology

Principal Investigators

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Michal Ciszewski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cardiology, Warsaw, Poland

Locations

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Institute of Cardiology

Warsaw, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type DERIVED
PMID: 21234920 (View on PubMed)

Other Identifiers

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2PO5C00527

Identifier Type: -

Identifier Source: org_study_id

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