Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)

November 12, 2009 updated by: University Medical Center Groningen

Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)

In this trial, the investigators will evaluate the effect of thrombus aspiration followed by stent implantation in improving myocardial blush grade in patients with acute non-ST-elevation myocardial infarction compared to conventional percutaneous coronary intervention (PCI).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) has shown that thrombus aspiration improves myocardial perfusion and clinical outcome compared to conventional primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction. Impaired myocardial perfusion due to spontaneous or angioplasty-induced embolization of atherothrombotic material also occurs in patients with Non-ST-elevation myocardial infarction (NSTEMI). The aim of this study is to determine whether thrombus aspiration before stent implantation will result in improved myocardial perfusion in patients with NSTEMI compared to conventional PCI.

The study is a single-centre, prospective, randomised trial with blinded evaluation of endpoints. The planned inclusion is 540 patients with acute NSTEMI who are candidates for urgent PCI.

If thrombus aspiration leads to significant improvement of myocardial perfusion in patients with acute NSTEMI it may become part of the standard interventional approach.

Study Type

Interventional

Enrollment (Anticipated)

540

Phase

  • 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

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of acute NSTEMI defined by

    • Chest pain suggestive for myocardial ischemia for at least 30 minutes,
    • Time from onset of symptoms of less than 72 hours
    • ECG with ST-segment shifts (depression of >0.1 mV in at least two contiguous leads or transient ST-segment elevation >0.1 mV in at least two contiguous leads for less than 30 minutes) and/or T-wave changes (inversion of >0.15 mV in at least two contiguous leads)
    • Positive cardiac troponin T >0,01 μg/L.
  • Clinical indication for urgent PCI of the ischemia-related target lesion as identified at coronary angiography

Exclusion Criteria:

  • Persistent ST-elevation of more than 0.1 mV in 2 or more leads
  • Presence of cardiogenic shock
  • Inability to obtain informed consent
  • Known existence of a life-threatening disease with a life expectancy of less than 6 months

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thrombus aspiration
Procedure: Thrombus aspiration followed by stent implantation
Export aspiration catheter 6F (Medtronics)
Active Comparator: Conventional percutaneous coronary intervention
Procedure: conventional PCI
balloon angioplasty and/or stent implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of myocardial blush grade 3 after PCI
Time Frame: During PCI procedure
During PCI procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Coronary angiographic outcomes
Time Frame: During PCI procedure
During PCI procedure
Histopathological outcomes of atherothrombotic material
Time Frame: After inclusion is stopped: mean 1 year (storage at -80 degrees Celcius)
After inclusion is stopped: mean 1 year (storage at -80 degrees Celcius)
Enzymatic infarct size
Time Frame: During hospital stay
During hospital stay
Electrocardiographic outcomes
Time Frame: 30 to 60 minutes after PCI
30 to 60 minutes after PCI
Clinical outcomes at 30 days and 1 year
Time Frame: 30 days till 1 year
30 days till 1 year

Collaborators and Investigators

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

Sponsor

University Medical Center Groningen

Collaborators

Netherlands Heart Foundation

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

December 1, 2007

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

November 6, 2009

First Submitted That Met QC Criteria

November 12, 2009

First Posted (Estimate)

November 13, 2009

Study Record Updates

Last Update Posted (Estimate)

November 13, 2009

Last Update Submitted That Met QC Criteria

November 12, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008B101

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.

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