Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study

University Medical Center Groningen540 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

540

Conditions

Non-ST-Elevation Myocardial Infarction

Interventions

Thrombus aspiration followed by stent implantationPROCEDURE

Export aspiration catheter 6F (Medtronics)

conventional PCIPROCEDURE

balloon angioplasty and/or stent implantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Incidence of myocardial blush grade 3 after PCI

Time frame: During PCI procedure

Secondary Outcomes

Coronary angiographic outcomes

Time frame: During PCI procedure

Histopathological outcomes of atherothrombotic material

Time frame: After inclusion is stopped: mean 1 year (storage at -80 degrees Celcius)

Enzymatic infarct size

Time frame: During hospital stay

Electrocardiographic outcomes

Time frame: 30 to 60 minutes after PCI

Clinical outcomes at 30 days and 1 year

Time frame: 30 days till 1 year

Central Contacts

Marthe A Kampinga, MD

CONTACT

+31503610444 m.a.kampinga@thorax.umcg.nl

Felix Zijlstra, MD PhD

CONTACT

+31503613238 f.zijlstra@thorax.umcg.nl

Data from ClinicalTrials.gov

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