|- candidate number||2484|
|- NTR Number||NTR914|
|- Date ISRCTN created||7-mrt-2007|
|- date ISRCTN requested||6-mrt-2007|
|- Date Registered NTR||21-feb-2007|
|- Secondary IDs||N/A |
|- Public Title||Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS). |
|- Scientific Title||Effectiveness of thrombus aspiration compared to balloon angioplasty on myocardial reperfusion during percutaneous coronary intervention in acute myocardial infarction.|
|- hypothesis||Thrombus aspiration compared to balloon angioplasty will improve myocardial reperfusion during primary percutaneous coronary intervention. |
|- Healt Condition(s) or Problem(s) studied||Thrombus aspiration , Respiration, Myocardial infarction , Myocardial reperfusion |
|- Inclusion criteria||1. A diagnosis of acute MI defined by chest pain suggestive for myocardial ischemia for at least 30 minutes, with a time from onset of symptoms of less than 12 hours, before hospital admission;|
2. An ECG with ST- segment elevation of more than 0.1 mV in 2 or more leads.
|- Exclusion criteria||1. Rescue 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 6 months.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2005|
|- planned closingdate||1-jan-2007|
|- Target number of participants||1080|
|- Interventions||Thrombus aspiration compared to conventional balloon angioplasty during primary percutaneous coronary intervention. |
|- Primary outcome||Angiographic myocardial blush grade of less than 2.|
|- Secondary outcome||1. Enzymatic infarct size;|
2. ST-segment elevation resolution;
3. Persistent ST-segment elevation;
4. Post-procedural distal embolization;
5. Major Adverse Cardiac Events at 30 days and 1 year.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD Tone Svilaas|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD Felix Zijlstra|
|- Sponsor/Initiator ||University Medical Center Groningen, Thoraxcenter, Dept Cardiology|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG) Thoraxcenter, Dept Cardiology|
|- Publications||Svilaas T, van der Horst IC, Zijlstra F.
Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS)--study design.
Am Heart J. 2006 Mar;151(3):597.e1-597.e7.
|- Brief summary||Background and objective: |
Embolization of atherothrombotic material is common during percutaneous coronary intervention (PCI) in acute myocardial infarction. Adjunctive devices for PCI to protect the microcirculation have been developed. We intend to determine whether aspiration of thrombotic material before stent implantation of the infarct related coronary artery results in improved myocardial perfusion compared with conventional primary PCI.
The Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) is a single-center, prospective, randomized trial with a planned inclusion of 1080 patients with ST elevation myocardial infarction. 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. The primary endpoint is angiographic myocardial blush grade of less than 2. Secondary endpoints are enzymatic infarct size, ST-segment elevation resolution and persistent ST-segment elevation, post-procedural distal embolization, and Major Adverse Cardiac Events at 30 days and 1 year.
If thrombus aspiration significantly improves myocardial perfusion, it will lend support to the use of this treatment as part of the standard approach in patients with acute myocardial infarction.
|- Main changes (audit trail)|
|- RECORD||21-feb-2007 - 4-nov-2009|