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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Clinical Centre of Serbia
Sponsor:
Collaborators:
Center of nuclear medicine
Institute for histology
Information provided by (Responsible Party):
Dejan Orlic, Clinical Centre of Serbia
ClinicalTrials.gov Identifier:
NCT01824641
First received: March 22, 2013
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Device: Eliminate aspiration catheter
Procedure: Conventional primary angioplasty
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Randomized Physiologic Assessment of Thrombus Aspiration in Patients With Acute ST-segment Elevation Myocardial Infarction Trial

Resource links provided by NLM:


Further study details as provided by Clinical Centre of Serbia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    IMR will be measured after final balloon inflation or stent implantation, an expected average of 45 minutes after sheath insertion


Secondary Outcome Measures:
  • Resolution of ST-segment elevation [ Time Frame: at 60 minutes after guiding catheter removal ] [ Designated as safety issue: No ]
    ST-segment resolution ≥70% 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 ] [ Designated as safety issue: No ]
    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)) [ Time Frame: in hospital course after primary PCI, an expected average of 5 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: within 24 hours and at 4 months after primary PCI ] [ Designated as safety issue: No ]
    left ventricle remodeling will be assessed on Echocardiography 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 ] [ Designated as safety issue: No ]
    infarct size will be determined by SPECT within 7-14 days and at 4 months after primary PCI


Estimated Enrollment: 128
Study Start Date: September 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824641

Contacts
Contact: Dejan Milasinovic, MD +381113613653 dejan_milasinovic@yahoo.com
Contact: Goran Stankovic, MD, PhD +381113615433 gorastan@sbb.rs

Locations
Serbia
Clinical center of Serbia Recruiting
Belgrade, Serbia, 11000
Contact: Milorad Tesic, MD    +381113615433    misa.tesic@gmail.com   
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         
Clinical Center of Serbia Recruiting
Belgrade, Serbia
Contact: Dejan Orlic    +381113615433      
Principal Investigator: Dejan Orlic, MD         
Sponsors and Collaborators
Clinical Centre of Serbia
Center of nuclear medicine
Institute for histology
Investigators
Principal Investigator: Dejan Orlic, MD Clinical Center of Serbia
  More Information

No publications provided

Responsible Party: Dejan Orlic, MD, Clinical Centre of Serbia
ClinicalTrials.gov Identifier: NCT01824641     History of Changes
Other Study ID Numbers: T113E4
Study First Received: March 22, 2013
Last Updated: April 2, 2013
Health Authority: Serbia: Ethics Committee
United States: Food and Drug Administration

Keywords provided by Clinical Centre of Serbia:
Acute myocardial infarction
Manual thrombus aspiration
Coronary physiology

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Thrombosis
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis

ClinicalTrials.gov processed this record on July 20, 2014