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

Primary Purpose

Acute Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Endeavor resolute or Resolute integrity (Medtronic)
Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Thrombus aspiration, Percutaneous coronary intervention

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

No aspiration

Thrombus aspiration

Arm Description

Outcomes

Primary Outcome Measures

The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization

Secondary Outcome Measures

All-cause Death
Cardiac death
Myocardial infarction(Q or non-Q)
Stent thrombosis by Academic Research Consortium definition
Target vessel revascularization (clinically- and ischemia-driven)
Target lesion revascularization (clinically- and ischemia-driven)
Post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow grade
Post-procedural Thrombolysis in Myocardial Infarction Myocardial Perfusion (TMP) grades
Left ventricular wall motion improvement
ST segment resolution on ECG after procedure

Full Information

First Posted
July 1, 2010
Last Updated
April 13, 2013
Sponsor
Ajou University School of Medicine
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT01156662
Brief Title
Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction
Acronym
ETAMI
Official Title
Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Thrombus aspiration, Percutaneous coronary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No aspiration
Arm Type
Active Comparator
Arm Title
Thrombus aspiration
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Endeavor resolute or Resolute integrity (Medtronic)
Intervention Description
PCI without thrombus aspiration
Intervention Type
Device
Intervention Name(s)
Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)
Intervention Description
PCI after thrombus aspiration
Primary Outcome Measure Information:
Title
The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization
Time Frame
12 months after index procedure
Secondary Outcome Measure Information:
Title
All-cause Death
Time Frame
1 month until 12 months after index procedure
Title
Cardiac death
Time Frame
1 month until 12 months after index procedure
Title
Myocardial infarction(Q or non-Q)
Time Frame
1 month until 12 months after index procedure
Title
Stent thrombosis by Academic Research Consortium definition
Time Frame
1 month until 12 months after index procedure
Title
Target vessel revascularization (clinically- and ischemia-driven)
Time Frame
1 month until 12 months after index procedure
Title
Target lesion revascularization (clinically- and ischemia-driven)
Time Frame
1 month until 12 months after index procedure
Title
Post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow grade
Time Frame
Day 0 (during PCI procedure)
Title
Post-procedural Thrombolysis in Myocardial Infarction Myocardial Perfusion (TMP) grades
Time Frame
Day 0 (during PCI procedure)
Title
Left ventricular wall motion improvement
Time Frame
12 months
Title
ST segment resolution on ECG after procedure
Time Frame
0 hour (at the end of procedure), 1 hour, and 24 hours after PCI procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jea Tahk, MD, PhD
Organizational Affiliation
Department of Cardiology, Ajou University School of Medicine, Ajou University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
Country
Korea, Republic of
Facility Name
Sejong General Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Bundang CHA General Hospital
City
Bundang
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Bundang
Country
Korea, Republic of
Facility Name
Dankook University Hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Daejeon ST. Mary's Hospital,The Catholic University of Korea
City
Daejeon
Country
Korea, Republic of
Facility Name
Konyang University Hospital
City
Daejon
Country
Korea, Republic of
Facility Name
Gangneung Asan Hospital
City
Gangneung
Country
Korea, Republic of
Facility Name
Kwandong University college of Medicine Myongji Hospital
City
Goyang
Country
Korea, Republic of
Facility Name
National Health Insurance Corporation ILSAN Hospital
City
Goyang
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Handong University Sunlin Hospital
City
Pohang
Country
Korea, Republic of
Facility Name
Inje University Pusan Paik Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Hallym University Kangdong Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea Univeristy Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
St. Carollo Hospital
City
Suncheon
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Facility Name
Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital
City
Wonju
Country
Korea, Republic of

12. IPD Sharing Statement

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Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction

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