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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Device: Endeavor resolute or Resolute integrity (Medtronic); Device: Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1400
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Bucheon, Korea, Republic of
    • Sejong General Hospital
  • Bundang, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Bundang, Korea, Republic of
    • Bundang CHA General Hospital
  • Cheonan, Korea, Republic of
    • Dankook University Hospital
  • Cheonan, Korea, Republic of
    • Soon Chun Hyang University Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Hospital
  • Daegu, Korea, Republic of
    • Yeungnam University Medical Center
  • Daejeon, Korea, Republic of
    • Daejeon ST. Mary's Hospital,The Catholic University of Korea
  • Daejon, Korea, Republic of
    • Konyang University Hospital
  • Gangneung, Korea, Republic of
    • GangNeung Asan Hospital
  • Goyang, Korea, Republic of
    • National Health Insurance Corporation Ilsan Hospital
  • Goyang, Korea, Republic of
    • Kwandong University college of Medicine Myongji Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Incheon, Korea, Republic of
    • Inha University Hospital
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Pohang, Korea, Republic of
    • Handong University Sunlin Hospital
  • Pusan, Korea, Republic of
    • Inje University Pusan Paik Hospital
  • Seoul, Korea, Republic of
    • Hallym University Kangdong Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • Yonsei University Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Yonsei University Severance Hospital
  • Seoul, Korea, Republic of
    • Hallym University Kangnam Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • Korea Univeristy Guro Hospital
  • Suncheon, Korea, Republic of
    • St. Carollo Hospital
  • Suwon, Korea, Republic of
    • Ajou University Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
  • Wonju, Korea, Republic of
    • Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization	12 months after index procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Collaborators: Medtronic
• Investigators: Principal Investigator: Seung-Jea Tahk, MD, PhD, Department of Cardiology, Ajou University School of Medicine, Ajou University Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): March 1, 2014
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: July 1, 2010
• First Submitted That Met QC Criteria: July 2, 2010
• First Posted (Estimate): July 5, 2010

Study Record Updates

• Last Update Posted (Estimate): April 16, 2013
• Last Update Submitted That Met QC Criteria: April 13, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Thrombus aspiration
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: ETAMI-2009