Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)
Primary Purpose
Non-ST-Elevation Myocardial Infarction
Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Thrombus aspiration followed by stent implantation
conventional PCI
Sponsored by
About this trial
This is an interventional treatment trial for Non-ST-Elevation Myocardial Infarction focused on measuring myocardial infarction, percutaneous coronary intervention, thrombus aspiration
Eligibility 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
Sites / Locations
- University Medical Center GroningenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional percutaneous coronary intervention
Thrombus aspiration
Arm Description
Outcomes
Primary Outcome Measures
Incidence of myocardial blush grade 3 after PCI
Secondary Outcome Measures
Coronary angiographic outcomes
Histopathological outcomes of atherothrombotic material
Enzymatic infarct size
Electrocardiographic outcomes
Clinical outcomes at 30 days and 1 year
Full Information
NCT ID
NCT01013038
First Posted
November 6, 2009
Last Updated
November 12, 2009
Sponsor
University Medical Center Groningen
Collaborators
Netherlands Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01013038
Brief Title
Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study
Acronym
TAPAS II
Official Title
Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Medical Center Groningen
Collaborators
Netherlands Heart Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ST-Elevation Myocardial Infarction
Keywords
myocardial infarction, percutaneous coronary intervention, thrombus aspiration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
540 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional percutaneous coronary intervention
Arm Type
Active Comparator
Arm Title
Thrombus aspiration
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Thrombus aspiration followed by stent implantation
Intervention Description
Export aspiration catheter 6F (Medtronics)
Intervention Type
Procedure
Intervention Name(s)
conventional PCI
Intervention Description
balloon angioplasty and/or stent implantation
Primary Outcome Measure Information:
Title
Incidence of myocardial blush grade 3 after PCI
Time Frame
During PCI procedure
Secondary Outcome Measure Information:
Title
Coronary angiographic outcomes
Time Frame
During PCI procedure
Title
Histopathological outcomes of atherothrombotic material
Time Frame
After inclusion is stopped: mean 1 year (storage at -80 degrees Celcius)
Title
Enzymatic infarct size
Time Frame
During hospital stay
Title
Electrocardiographic outcomes
Time Frame
30 to 60 minutes after PCI
Title
Clinical outcomes at 30 days and 1 year
Time Frame
30 days till 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marthe A Kampinga, MD
Phone
+31503610444
Email
m.a.kampinga@thorax.umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Felix Zijlstra, MD PhD
Phone
+31503613238
Email
f.zijlstra@thorax.umcg.nl
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marthe A Kampinga, MD
Phone
+31503610444
Email
m.a.kampinga@thorax.umcg.nl
12. IPD Sharing Statement
Learn more about this trial
Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study
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