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

Myocardial Infarction Clinical Trial

— PATA-STEMI  

Official title:

The Randomized Physiologic Assessment of Thrombus Aspiration in Patients With Acute ST-segment Elevation Myocardial Infarction Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01824641
• Other study ID #: T113E4
• Status: Recruiting
• Phase: Phase 3
• First received: March 22, 2013
• Last updated: April 2, 2013
• Start date: September 2012
• Est. completion date: November 2013

Study information

• Verified date: April 2013
• Source: Clinical Centre of Serbia
• Contact: Dejan Milasinovic, MD
• Phone: +381113613653
• Email: dejan_milasinovic[@]yahoo.com
• Is FDA regulated: No
• Health authority: Serbia: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: November 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Device:
• Eliminate aspiration catheter
Eliminate aspiration catheter

Procedure:
• Conventional primary angioplasty
Primary angioplasty without thrombus aspiration

Locations

Country	Name	City	State
Serbia	Clinical center of Serbia	Belgrade
Serbia	Clinical Center of Serbia	Belgrade

Sponsors (3)

Lead Sponsor	Collaborator
Clinical Centre of Serbia	Center of nuclear medicine, Institute for histology

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IMR (mmHg seconds) in thrombus aspiration compared to conventional PCI group	IMR will be measured after final balloon inflation or stent implantation, an expected average of 45 minutes after sheath insertion	At the end of the primary PCI , an expected average of 45 minutes after sheath insertion	No
Secondary	Resolution of ST-segment elevation	ST-segment resolution =70% at 60 minutes after guiding catheter removal	at 60 minutes after guiding catheter removal	No
Secondary	myocardial blush grade (0-3)	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	at final angiogram, an expected average of 55 minutes after sheath insertion	No
Secondary	infarct size assessed by peak enzyme release (Troponin, creatine kinase MB (CK-MB))	infarct size will be determined based on peak enzyme release (Troponin, CK-MB) during in-hospital stay, an expected average of 5 days	in hospital course after primary PCI, an expected average of 5 days	No
Secondary	indices of left ventricle remodeling on Echocardiography	left ventricle remodeling will be assessed on Echocardiography within 24 hours and at 4 months after primary PCI	within 24 hours and at 4 months after primary PCI	No
Secondary	infarct size determined by SPECT	infarct size will be determined by SPECT within 7-14 days and at 4 months after primary PCI	within 7-14 days and at 4 months after primary PCI	No