Physiologic Assessment of Thrombus Aspiration in Acute ST-segment Elevation Myocardial Infarction Patients

Phase 3

• Conditions: Myocardial Infarction
• Interventions: Device: Eliminate aspiration catheter; Procedure: Conventional primary angioplasty

• Registration Number: NCT01824641
• Lead Sponsor: Clinical Centre of Serbia

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-03-22
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-02
• Last Update Submitted: 2013-04-02
• Study First Posted: 2013-04-05
• Last Update Posted: 2013-04-05
• Primary Completion: 2013-05
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eliminate	Eliminate aspiration catheter	Eliminate aspiration catheter
Conventional primary angioplasty	Conventional primary angioplasty	Patients treated with conventional primary angioplasty

Primary Outcome Measures

Name	Time	Method
IMR (mmHg seconds) in thrombus aspiration compared to conventional PCI group	At the end of the primary PCI , an expected average of 45 minutes after sheath insertion	IMR will be measured after final balloon inflation or stent implantation, an expected average of 45 minutes after sheath insertion

Secondary Outcome Measures

Name	Time	Method
Resolution of ST-segment elevation	at 60 minutes after guiding catheter removal	ST-segment resolution ≥70% at 60 minutes after guiding catheter removal
myocardial blush grade (0-3)	at final angiogram, an expected average of 55 minutes after sheath insertion	myocardial blush grade will be assessed after IMR measurements, following the final balloon inflation or stent implantation, an expected average of 55 minutes after sheath insertion
infarct size assessed by peak enzyme release (Troponin, creatine kinase MB (CK-MB))	in hospital course after primary PCI, an expected average of 5 days	infarct size will be determined based on peak enzyme release (Troponin, CK-MB) during in-hospital stay, an expected average of 5 days
indices of left ventricle remodeling on Echocardiography	within 24 hours and at 4 months after primary PCI	left ventricle remodeling will be assessed on Echocardiography within 24 hours and at 4 months after primary PCI
infarct size determined by SPECT	within 7-14 days and at 4 months after primary PCI	infarct size will be determined by SPECT within 7-14 days and at 4 months after primary PCI

Trial Locations

Locations (2)

Clinical center of Serbia; 🇷🇸 Belgrade, Serbia

Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia