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

April 2, 2013 updated by: Dejan Orlic, Clinical Centre of Serbia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Goran Stankovic, MD, PhD
  • Phone Number: +381113615433
  • Email: gorastan@sbb.rs

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Center of Serbia
        • Contact:
        • Sub-Investigator:
          • Miodrag Ostojic, Prof
        • Sub-Investigator:
          • Branko Beleslin, Prof
        • Sub-Investigator:
          • Goran Stankovic, Prof
        • Sub-Investigator:
          • Sinisa Stojkovic, Professor
        • Sub-Investigator:
          • Vladan Vukcevic, Professor
        • Sub-Investigator:
          • Milica Borovic, Professor
        • Sub-Investigator:
          • Dragana Sobic-Saranovic, Professor
        • Sub-Investigator:
          • Milorad Tesic, MD
        • Sub-Investigator:
          • Dejan Milasinovic, MD
        • Sub-Investigator:
          • Milan Dobric, MD
        • Sub-Investigator:
          • Zlatko Mehmedbegovic, MD
        • Sub-Investigator:
          • Milan Nedeljkovic, Professor
        • Sub-Investigator:
          • Milorad Zivkovic, MD
        • Sub-Investigator:
          • Vladimir Dedovic, MD
      • Belgrade, Serbia
        • Recruiting
        • Clinical Center of Serbia
        • Contact:
          • Dejan Orlic
          • Phone Number: +381113615433
        • Principal Investigator:
          • Dejan Orlic, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Eliminate
Eliminate aspiration catheter
Device: Eliminate aspiration catheter
Eliminate aspiration catheter
ACTIVE_COMPARATOR: Conventional primary angioplasty
Patients treated with conventional primary angioplasty
Procedure: Conventional primary angioplasty
Primary angioplasty without thrombus aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IMR (mmHg seconds) in thrombus aspiration compared to conventional PCI group
Time Frame: 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
At the end of the primary PCI , an expected average of 45 minutes after sheath insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of ST-segment elevation
Time Frame: at 60 minutes after guiding catheter removal
ST-segment resolution ≥70% at 60 minutes after guiding catheter removal
at 60 minutes after guiding catheter removal
myocardial blush grade (0-3)
Time Frame: 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
at final angiogram, an expected average of 55 minutes after sheath insertion
infarct size assessed by peak enzyme release (Troponin, creatine kinase MB (CK-MB))
Time Frame: 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
in hospital course after primary PCI, an expected average of 5 days
indices of left ventricle remodeling on Echocardiography
Time Frame: 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
within 24 hours and at 4 months after primary PCI
infarct size determined by SPECT
Time Frame: 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
within 7-14 days and at 4 months after primary PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Centre of Serbia

Collaborators

Center of nuclear medicine
Institute for histology

Investigators

  • Principal Investigator: Dejan Orlic, MD, Clinical Center of Serbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ANTICIPATED)

May 1, 2013

Study Completion (ANTICIPATED)

November 1, 2013

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (ESTIMATE)

April 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 5, 2013

Last Update Submitted That Met QC Criteria

April 2, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T113E4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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