Clinical trial NCT01013038: Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study
Official title: Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-ST-Elevation Myocardial Infarction
Keywords: myocardial infarction
percutaneous coronary intervention
thrombus aspiration
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Netherlands Heart Foundation
First posted: 2009-11-13
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of myocardial blush grade 3 after PCI
timeFrame: During PCI procedure
Secondary outcomes:
measure: Coronary angiographic outcomes
timeFrame: During PCI procedure
measure: Histopathological outcomes of atherothrombotic material
timeFrame: After inclusion is stopped: mean 1 year (storage at -80 degrees Celcius)
measure: Enzymatic infarct size
timeFrame: During hospital stay
measure: Electrocardiographic outcomes
timeFrame: 30 to 60 minutes after PCI
measure: Clinical outcomes at 30 days and 1 year
timeFrame: 30 days till 1 year
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References: