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

April 13, 2013 updated by: Seung-Jea Tahk, Ajou University School of Medicine
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization
Time Frame: 12 months after index procedure
12 months after index procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
All-cause Death
Time Frame: 1 month until 12 months after index procedure
1 month until 12 months after index procedure
Cardiac death
Time Frame: 1 month until 12 months after index procedure
1 month until 12 months after index procedure
Myocardial infarction(Q or non-Q)
Time Frame: 1 month until 12 months after index procedure
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
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
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
1 month until 12 months after index procedure
Post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow grade
Time Frame: Day 0 (during PCI procedure)
Day 0 (during PCI procedure)
Post-procedural Thrombolysis in Myocardial Infarction Myocardial Perfusion (TMP) grades
Time Frame: Day 0 (during PCI procedure)
Day 0 (during PCI procedure)
Left ventricular wall motion improvement
Time Frame: 12 months
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
0 hour (at the end of procedure), 1 hour, and 24 hours after PCI procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ajou University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seung-Jea Tahk, MD, PhD, Department of Cardiology, Ajou University School of Medicine, Ajou University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ETAMI-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings