Clinical trial NCT01156662: Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction
Official title: Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Keywords: Thrombus aspiration
Percutaneous coronary intervention
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2010-07-05
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization
timeFrame: 12 months after index procedure
Secondary outcomes:
measure: All-cause Death
timeFrame: 1 month until 12 months after index procedure
measure: Cardiac death
timeFrame: 1 month until 12 months after index procedure
measure: Myocardial infarction(Q or non-Q)
timeFrame: 1 month until 12 months after index procedure
measure: Stent thrombosis by Academic Research Consortium definition
timeFrame: 1 month until 12 months after index procedure
measure: Target vessel revascularization (clinically- and ischemia-driven)
timeFrame: 1 month until 12 months after index procedure
measure: Target lesion revascularization (clinically- and ischemia-driven)
timeFrame: 1 month until 12 months after index procedure
measure: Post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow grade
timeFrame: Day 0 (during PCI procedure)
measure: Post-procedural Thrombolysis in Myocardial Infarction Myocardial Perfusion (TMP) grades
timeFrame: Day 0 (during PCI procedure)
measure: Left ventricular wall motion improvement
timeFrame: 12 months
measure: ST segment resolution on ECG after procedure
timeFrame: 0 hour (at the end of procedure), 1 hour, and 24 hours after PCI procedure
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon
country: Korea, Republic of
facility: Sejong General Hospital
city: Bundang
country: Korea, Republic of
facility: Bundang CHA General Hospital
city: Bundang
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Daejeon ST. Mary's Hospital,The Catholic University of Korea
city: Daejon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Goyang
country: Korea, Republic of
facility: Kwandong University college of Medicine Myongji Hospital
city: Goyang
country: Korea, Republic of
facility: National Health Insurance Corporation ILSAN Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Pohang
country: Korea, Republic of
facility: Handong University Sunlin Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Univeristy Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Suncheon
country: Korea, Republic of
facility: St. Carollo Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital
Study officials:
affiliation: Department of Cardiology, Ajou University School of Medicine, Ajou University Medical Center
name: Seung-Jea Tahk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: