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ISRCTN
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ISRCTN16716833
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ClinicalTrials.gov identifier
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Public title
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Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study
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Scientific title
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Effectiveness of thrombus aspiration compared to balloon angioplasty on myocardial reperfusion during percutaneous coronary intervention in acute myocardial infarction
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Acronym
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TAPAS
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Serial number at source
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NTR914
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Study hypothesis
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Thrombus aspiration compared to balloon angioplasty will improve myocardial reperfusion during primary percutaneous coronary intervention.
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Lay summary
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Ethics approval
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Ethics approval received from the local ethics committee.
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Study design
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Randomised, active controlled, parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Myocardial infarction
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Participants - inclusion criteria
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1. A diagnosis of acute myocardial infarction (MI) defined by chest pain suggestive for myocardial ischaemia for at least 30 minutes, with a time from onset of symptoms of less than 12 hours, before hospital admission
2. An electrocardiogram (ECG) with ST-segment elevation of more than 0.1 mV in two or more leads
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Participants - exclusion criteria
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1. Rescue percutaneous coronary intervention (PCI) after thrombolytic therapy
2. Inability to obtain informed consent
3. Known existence of a life-threatening disease with a life expectancy of less than six months
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Anticipated start date
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01/01/2005
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Anticipated end date
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01/01/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1080
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Interventions
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Thrombus aspiration compared to conventional balloon angioplasty during primary percutaneous coronary intervention. Patients are assigned to treatment with thrombus aspiration with the 6F Export Aspiration Catheter (Medtronic Corporation, Santa Rosa, California, USA) or to balloon angioplasty before stent implantation in the infarct related artery.
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Primary outcome measure(s)
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Angiographic myocardial blush grade of less than two
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Secondary outcome measure(s)
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1. Enzymatic infarct size
2. ST-segment elevation resolution
3. Persistent ST-segment elevation
4. Post-procedural distal embolisation
5. Major adverse cardiac events at 30 days and one year
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Sources of funding
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University Medical Centre Groningen (UMCG) (The Netherlands)
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Trial website
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Publications
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Protocol in:
1. 2006 study design: http://www.ncbi.nlm.nih.gov/pubmed/16504620
Results in:
2. 2008 thrombus aspiration results: http://www.ncbi.nlm.nih.gov/pubmed/18256391
3. 2008 1-year follow-up study results: http://www.ncbi.nlm.nih.gov/pubmed/18539223
4. 2009 substudy results in http://www.ncbi.nlm.nih.gov/pubmed/19168868
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Contact name
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Dr
Tone
Svilaas
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Address
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University Medical Centre Groningen
Thorax Centre
Department of Cardiology
P.O. Box 30001
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City/town
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Groningen
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Zip/Postcode
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9700 RB
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Country
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Netherlands
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Tel
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+31 (0)50 361 0444
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Fax
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+31 (0)50 361 4391
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Email
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t.svilaas@thorax.umcg.nl
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Sponsor
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University Medical Centre Groningen (UMCG) (The Netherlands)
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Address
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Thorax Centre
Department of Cardiology
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City/town
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Groningen
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Zip/Postcode
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9700 RB
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Country
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Netherlands
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Sponsor website:
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http://www.umcg.nl/azg/nl/english/azg/#http://www.umcg.nl/azg/nl/english/azg/
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Date applied
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07/03/2007
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Last edited
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27/01/2009
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Date ISRCTN assigned
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07/03/2007
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