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

Phase 4

• Conditions: Non-ST-Elevation Myocardial Infarction
• Interventions: Procedure: Thrombus aspiration followed by stent implantation; Procedure: conventional PCI

• Registration Number: NCT01013038
• Lead Sponsor: University Medical Center Groningen

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.

Study Timeline

• Study Start: 2007-12
• Status Verified: 2009-11
• Study First Submitted: 2009-11-06
• Study First Submitted QC: 2009-11-12
• Last Update Submitted: 2009-11-12
• Study First Posted: 2009-11-13
• Last Update Posted: 2009-11-13
• Primary Completion: 2011-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 540

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thrombus aspiration	Thrombus aspiration followed by stent implantation	-
Conventional percutaneous coronary intervention	conventional PCI	-

Primary Outcome Measures

Name	Time	Method
Incidence of myocardial blush grade 3 after PCI	During PCI procedure

Secondary Outcome Measures

Name	Time	Method
Histopathological outcomes of atherothrombotic material	After inclusion is stopped: mean 1 year (storage at -80 degrees Celcius)
Enzymatic infarct size	During hospital stay
Clinical outcomes at 30 days and 1 year	30 days till 1 year
Coronary angiographic outcomes	During PCI procedure
Electrocardiographic outcomes	30 to 60 minutes after PCI

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands