Thrombectomy in Acute Myocardial Infarction

Phase 3

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Procedure: Thrombectomy; Procedure: Primary angioplasty

• Registration Number: NCT00675480
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2008-05-07
• Study First Submitted QC: 2008-05-08
• Study First Posted: 2008-05-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-28
• Last Update Posted: 2009-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T	Thrombectomy	Patients treated with thrombectomy: T
P	Primary angioplasty	Patients treated with standard PCI with stent implantation

Primary Outcome Measures

Name	Time	Method
Myocardial salvage index assessed with SPECT MIBI.	5-8 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Cardiology; 🇵🇱 Warsaw, Poland