- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01013038
Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)
Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Marthe A Kampinga, MD
- Phone Number: +31503610444
- Email: m.a.kampinga@thorax.umcg.nl
Study Contact Backup
- Name: Felix Zijlstra, MD PhD
- Phone Number: +31503613238
- Email: f.zijlstra@thorax.umcg.nl
Study Locations
-
-
-
Groningen, Netherlands
- Recruiting
- University Medical Center Groningen
-
Contact:
- Marthe A Kampinga, MD
- Phone Number: +31503610444
- Email: m.a.kampinga@thorax.umcg.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Export aspiration catheter 6F (Medtronics)
|
Active Comparator: Conventional percutaneous coronary intervention
|
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
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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