Thrombectomy in Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— TAMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675480
• Other study ID #: 2PO5C00527
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2008
• Last updated: January 28, 2009
• Start date: November 2004
• Est. completion date: September 2008

Study information

• Verified date: January 2009
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Thrombectomy
Aspiration Thrombectomy prior to stent implantation in patients with ST segment elevation myocardial infarction
• Primary angioplasty
Standard primary angioplasty with stent implantation

Locations

Country	Name	City	State
Poland	Institute of Cardiology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial salvage index assessed with SPECT MIBI.		5-8 days	No
Secondary	In hospital mortality		in hospital, before discharge	Yes
Secondary	ST segment resolution after PCI;		90 minutes	No
Secondary	CK-MB AUC		72 hours	No
Secondary	Corrected TIMI frame count		immediately post PCI	No