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

Acute Myocardial Infarction Clinical Trial

— ETAMI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01156662
• Other study ID #: ETAMI-2009
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 1, 2010
• Last updated: April 13, 2013
• Start date: March 2009
• Est. completion date: April 2014

Study information

• Verified date: April 2013
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1400
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• Endeavor resolute or Resolute integrity (Medtronic)
PCI without thrombus aspiration
• Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)
PCI after thrombus aspiration

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Ajou University School of Medicine	Medtronic

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization		12 months after index procedure	Yes
Secondary	All-cause Death		1 month until 12 months after index procedure	Yes
Secondary	Cardiac death		1 month until 12 months after index procedure	Yes
Secondary	Myocardial infarction(Q or non-Q)		1 month until 12 months after index procedure	Yes
Secondary	Stent thrombosis by Academic Research Consortium definition		1 month until 12 months after index procedure	Yes
Secondary	Target vessel revascularization (clinically- and ischemia-driven)		1 month until 12 months after index procedure	No
Secondary	Target lesion revascularization (clinically- and ischemia-driven)		1 month until 12 months after index procedure	No
Secondary	Post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow grade		Day 0 (during PCI procedure)	No
Secondary	Post-procedural Thrombolysis in Myocardial Infarction Myocardial Perfusion (TMP) grades		Day 0 (during PCI procedure)	No
Secondary	Left ventricular wall motion improvement		12 months	No
Secondary	ST segment resolution on ECG after procedure		0 hour (at the end of procedure), 1 hour, and 24 hours after PCI procedure	No