No registrations found.
ID
Source
Brief title
Health condition
thrombus aspiration; percutaneous coronary intervention: myocardial infarction; myocardial reperfusion
Sponsors and support
Thoraxcenter, Dept Cardiology
Thoraxcenter, Dept Cardiology
Intervention
Outcome measures
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.
Background 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.
Study design:
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.
Implications:
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.
Study objective
Thrombus aspiration compared to balloon angioplasty will improve myocardial reperfusion during primary percutaneous coronary intervention.
Study design
N/A
Intervention
Thrombus aspiration compared to conventional balloon angioplasty during primary percutaneous coronary intervention.
Thoraxcenter, Dept Cardiology
PO Box 30 0001
Tone Svilaas
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 - (0) 50 - 3610444
t.svilaas@thorax.umcg.nl
Thoraxcenter, Dept Cardiology
PO Box 30 0001
Tone Svilaas
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 - (0) 50 - 3610444
t.svilaas@thorax.umcg.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL890 |
| NTR-old | NTR914 |
| Other | : N/A |
| ISRCTN | ISRCTN16716833 |
Summary results
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.