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Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction (ETAMI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Seung-Jea Tahk, Ajou University School of Medicine.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01156662
First Posted: July 5, 2010
Last Update Posted: April 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Seung-Jea Tahk, Ajou University School of Medicine
  Purpose
The present study was designed to investigate whether the thrombus aspiration using Export Aspiration Catheter (Medtronic Corporation, California, USA) during primary percutaneous coronary intervention (PCI) in acute myocardial infarction improve clinical outcomes.

Condition Intervention Phase
Acute Myocardial Infarction Device: Endeavor resolute or Resolute integrity (Medtronic) Device: Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Seung-Jea Tahk, Ajou University School of Medicine:

Primary Outcome Measures:
  • The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization [ Time Frame: 12 months after index procedure ]

Secondary Outcome Measures:
  • All-cause Death [ Time Frame: 1 month until 12 months after index procedure ]
  • Cardiac death [ Time Frame: 1 month until 12 months after index procedure ]
  • Myocardial infarction(Q or non-Q) [ Time Frame: 1 month until 12 months after index procedure ]
  • Stent thrombosis by Academic Research Consortium definition [ Time Frame: 1 month until 12 months after index procedure ]
  • Target vessel revascularization (clinically- and ischemia-driven) [ Time Frame: 1 month until 12 months after index procedure ]
  • Target lesion revascularization (clinically- and ischemia-driven) [ Time Frame: 1 month until 12 months after index procedure ]
  • Post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow grade [ Time Frame: Day 0 (during PCI procedure) ]
  • Post-procedural Thrombolysis in Myocardial Infarction Myocardial Perfusion (TMP) grades [ Time Frame: Day 0 (during PCI procedure) ]
  • Left ventricular wall motion improvement [ Time Frame: 12 months ]
  • ST segment resolution on ECG after procedure [ Time Frame: 0 hour (at the end of procedure), 1 hour, and 24 hours after PCI procedure ]

Estimated Enrollment: 1400
Study Start Date: March 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: No aspiration Device: Endeavor resolute or Resolute integrity (Medtronic)
PCI without thrombus aspiration
Active Comparator: Thrombus aspiration Device: Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)
PCI after thrombus aspiration

Detailed Description:
Primary percutaneous coronary intervention (PCI) is the preferred strategy for immediate revascularization in patients with acute ST-elevation myocardial infarction (STEMI). A meta-analysis of trials comparing primary PCI to fibrinolytic therapy showed a mortality benefit to the invasive approach. However, although TIMI III flow is achieved in the culprit epicardial vessel in the majority of patients, lack of tissue-level reperfusion is observed in approximately 30% of patients as manifested by persistence of chest pain and ST-segment elevation. Many strategies have tried to overcome this problem, from mechanical thrombectomy and distal protection devices to myocardial preserving agents. The purpose of present study is to investigate the efficacy of the thrombus aspiration using Export Aspiration Catheter (Medtronic Corporation, California, USA) during primary PCI in acute myocardial infarction.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with first ST-elevation myocardial infarction who undergo primary PCI within 12 hours after symptom onset
  • Patients who are eligible for PCI

Exclusion criteria

  • History of bleeding diathesis or coagulopathy
  • Pregnant
  • Known hypersensitivity or contra-indication to contrast agent
  • Left main disease
  • In-stent restenosis lesion
  • Graft vessels lesion
  • Chronic total occlusion lesion
  • Renal dysfunction, creatinine more than 2.0 mg/dL
  • Contraindication to aspirin, clopidogrel or cilostazol
  • Prior PCI or bypass surgery
  • Old myocardial infarction
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156662


Locations
Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang, Korea, Republic of
Sejong General Hospital
Bucheon, Korea, Republic of
Bundang CHA General Hospital
Bundang, Korea, Republic of
Seoul National University Bundang Hospital
Bundang, Korea, Republic of
Dankook University Hospital
Cheonan, Korea, Republic of
Soon Chun Hyang University Hospital
Cheonan, Korea, Republic of
Keimyung University Dongsan Hospital
Daegu, Korea, Republic of
Yeungnam University Medical Center
Daegu, Korea, Republic of
Daejeon ST. Mary's Hospital,The Catholic University of Korea
Daejeon, Korea, Republic of
Konyang University Hospital
Daejon, Korea, Republic of
Gangneung Asan Hospital
Gangneung, Korea, Republic of
Kwandong University college of Medicine Myongji Hospital
Goyang, Korea, Republic of
National Health Insurance Corporation ILSAN Hospital
Goyang, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Handong University Sunlin Hospital
Pohang, Korea, Republic of
Inje University Pusan Paik Hospital
Pusan, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
Seoul, Korea, Republic of
Korea Univeristy Guro Hospital
Seoul, Korea, Republic of
Yonsei University Gangnam Severance Hospital
Seoul, Korea, Republic of
Yonsei University Severance Hospital
Seoul, Korea, Republic of
St. Carollo Hospital
Suncheon, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital
Wonju, Korea, Republic of
Sponsors and Collaborators
Ajou University School of Medicine
Medtronic
Investigators
Principal Investigator: Seung-Jea Tahk, MD, PhD Department of Cardiology, Ajou University School of Medicine, Ajou University Medical Center
  More Information

Responsible Party: Seung-Jea Tahk, Dr., Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01156662     History of Changes
Other Study ID Numbers: ETAMI-2009
First Submitted: July 1, 2010
First Posted: July 5, 2010
Last Update Posted: April 16, 2013
Last Verified: April 2013

Keywords provided by Seung-Jea Tahk, Ajou University School of Medicine:
Thrombus aspiration
Percutaneous coronary intervention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases