Thrombectomy in Acute Myocardial Infarction - Full Text View

Sponsored by:	Institute of Cardiology, Warsaw, Poland
Information provided by:	Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:	NCT00675480

Purpose

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

Condition	Intervention	Phase
Acute Myocardial Infarction	Procedure: Thrombectomy Procedure: Primary angioplasty	Phase III

MedlinePlus related topics: Angioplasty Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Aspiration Thrombectomy as an Adjunctive Therapy to Primary Angioplasty in Patients With ST Segment Elevation Myocardial Infarction

Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:

Myocardial salvage index assessed with SPECT MIBI. [ Time Frame: 5-8 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

In hospital mortality [ Time Frame: in hospital, before discharge ] [ Designated as safety issue: Yes ]
ST segment resolution after PCI; [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
CK-MB AUC [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Corrected TIMI frame count [ Time Frame: immediately post PCI ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	November 2004
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
T: Experimental Patients treated with thrombectomy: T	Procedure: Thrombectomy Aspiration Thrombectomy prior to stent implantation in patients with ST segment elevation myocardial infarction
P: Active Comparator Patients treated with standard PCI with stent implantation	Procedure: Primary angioplasty Standard primary angioplasty with stent implantation

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675480

Contacts

Contact: Michał Ciszewski, MD, PhD	+48 22 3434272	mciszewski@ikard.pl
Contact: Jerzy Pregowski, MD	+48 22 3434340	jerzy_pregowski@yahoo.com

Locations

Poland
Institute of Cardiology	Recruiting
Warsaw, Poland, 04-628
Contact: Michał Ciszewski, MD, PhD +48 22 3434272 mciszewski@ikard.pl
Contact: Jerzy Pregowski, MD +48 22 3434340 jerzy_pregowski@yahoo.com
Principal Investigator: Michał Ciszewski, MD, PhD

Sponsors and Collaborators

Institute of Cardiology, Warsaw, Poland

Investigators

Principal Investigator:

Michal Ciszewski, MD, PhD

Institute of Cardiology, Warsaw, Poland

More Information

Responsible Party:	Institute of Cardiology ( Michał Ciszewski, MD, PhD )
Study ID Numbers:	2PO5C00527
Study First Received:	May 7, 2008
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00675480
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Institute of Cardiology, Warsaw, Poland:

myocardial infarction, thrombectomy, salvage index

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009