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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University Medical Centre Groningen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Netherlands Heart Foundation
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01013038
First received: November 6, 2009
Last updated: November 12, 2009
Last verified: November 2009
  Purpose

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).


Condition Intervention Phase
Non-ST-Elevation Myocardial Infarction
Procedure: Thrombus aspiration followed by stent implantation
Procedure: conventional PCI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Incidence of myocardial blush grade 3 after PCI [ Time Frame: During PCI procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Coronary angiographic outcomes [ Time Frame: During PCI procedure ] [ Designated as safety issue: No ]
  • Histopathological outcomes of atherothrombotic material [ Time Frame: After inclusion is stopped: mean 1 year (storage at -80 degrees Celcius) ] [ Designated as safety issue: No ]
  • Enzymatic infarct size [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]
  • Electrocardiographic outcomes [ Time Frame: 30 to 60 minutes after PCI ] [ Designated as safety issue: No ]
  • Clinical outcomes at 30 days and 1 year [ Time Frame: 30 days till 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 540
Study Start Date: December 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional percutaneous coronary intervention Procedure: conventional PCI
balloon angioplasty and/or stent implantation
Experimental: Thrombus aspiration Procedure: Thrombus aspiration followed by stent implantation
Export aspiration catheter 6F (Medtronics)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013038

Contacts
Contact: Marthe A Kampinga, MD +31503610444 m.a.kampinga@thorax.umcg.nl
Contact: Felix Zijlstra, MD PhD +31503613238 f.zijlstra@thorax.umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: Marthe A Kampinga, MD    +31503610444    m.a.kampinga@thorax.umcg.nl   
Sponsors and Collaborators
University Medical Centre Groningen
Netherlands Heart Foundation
  More Information

No publications provided

Responsible Party: Marthe Anna Kampinga, MD & Felix Zijlstra, MD PhD, University Medical Center Groningen, Thoraxcenter
ClinicalTrials.gov Identifier: NCT01013038     History of Changes
Other Study ID Numbers: 2008B101
Study First Received: November 6, 2009
Last Updated: November 12, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
myocardial infarction
percutaneous coronary intervention
thrombus aspiration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Thrombosis
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis

ClinicalTrials.gov processed this record on July 10, 2014