Physiologic Assessment of Thrombus Aspiration in Acute ST-segment Elevation Myocardial Infarction Patients (PATA-STEMI)

Clinical Centre of Serbia

Status and phase: Unknown; Phase 3

Conditions: Myocardial Infarction

Treatments: Procedure: Conventional primary angioplasty; Device: Eliminate aspiration catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01824641

T113E4

Details and patient eligibility

About

The Physiologic Assessment of Thrombus Aspiration in ST-segment Elevation Myocardial Infarction (PATA-STEMI) trial is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first ST-segment elevation myocardial infarction (STEMI). Patients are, before coronary angiography, randomly assigned to thrombus aspiration using 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to conventional primary percutaneous coronary intervention (PCI). The primary endpoint is index of microcirculatory resistance (IMR), measured in infarct-related artery, in thrombus aspiration compared to conventional PCI group.

Full description

Background and Objective Routine thrombus aspiration is superior to conventional primary PCI in terms of improved myocardial perfusion in STEMI patients. However, myocardial perfusion after thrombus aspiration has not been evaluated by a quantitative, invasive method. Investigators intend to determine whether thrombus aspiration of the infarct-related artery increases myocardial perfusion, as measured by IMR, compared to conventional primary PCI.

Study design PATA-STEMI is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first STEMI. Patients are randomly assigned, before coronary angiography, to thrombus aspiration using the 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to conventional primary PCI. The IMR will be determined in infarct-related artery and non-infarct-related arteries without critical stenosis to measure microcirculatory resistance. The primary endpoint is defined as IMR in infarct-related artery in thrombus aspiration compared to conventional PCI group. Secondary end points are myocardial perfusion grade and resolution of ST-segment elevation, infarct size and left ventricle remodeling, as assessed by echocardiographic indices. Transthoracic echocardiography will be conducted within 24 hours and at 4 months after the primary PCI.

Implications: If manual thrombus aspiration reduces microcirculatory resistance, indicating improved myocardial perfusion, as compared to conventional PCI, it might become the preferred strategy in patients with STEMI.

Enrollment: 128 estimated patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All consecutive patients with STEMI
• chest pain onset ≤12h, or >12 h with persistent ST-segment elevation
• hemodynamically stable patients

Exclusion criteria

• patients without diagnosis of STEMI (pericarditis, for example)
• no written informed consent obtained
• prior Q or non-Q MI
• prior resuscitation
• prior thrombolysis
• prior surgical myocardial revascularisation
• life expectancy <6 months
• periprocedural death

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

Eliminate

Experimental group

Description:

Eliminate aspiration catheter

Treatment:

Device: Eliminate aspiration catheter

Conventional primary angioplasty

Active Comparator group

Description:

Patients treated with conventional primary angioplasty

Treatment:

Procedure: Conventional primary angioplasty