Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)

University Medical Center Groningen (UMCG)

Status and phase

Unknown

Phase 4

Conditions

Non-ST-Elevation Myocardial Infarction

Treatments

Procedure: Thrombus aspiration followed by stent implantation

Procedure: conventional PCI

Study type

Interventional

Funder types

Other

Identifiers

NCT01013038

2008B101

Details and patient eligibility

About

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).

Full 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.

Enrollment

540 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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