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Sponsored by: |
Institute of Cardiology, Warsaw, Poland |
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Information provided by: | Institute of Cardiology, Warsaw, Poland |
ClinicalTrials.gov Identifier: | NCT00675480 |
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 |
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Acute Myocardial Infarction |
Procedure: Thrombectomy Procedure: Primary angioplasty |
Phase III |
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 |
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 |
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T: Experimental
Patients treated with thrombectomy: T
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Procedure: Thrombectomy
Aspiration Thrombectomy prior to stent implantation in patients with ST segment elevation myocardial infarction
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P: Active Comparator
Patients treated with standard PCI with stent implantation
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Procedure: Primary angioplasty
Standard primary angioplasty with stent implantation
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michał Ciszewski, MD, PhD | +48 22 3434272 | mciszewski@ikard.pl |
Contact: Jerzy Pregowski, MD | +48 22 3434340 | jerzy_pregowski@yahoo.com |
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 |
Principal Investigator: | Michal Ciszewski, MD, PhD | Institute of Cardiology, Warsaw, Poland |
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 |
myocardial infarction, thrombectomy, salvage index |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |