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

This study is currently recruiting participants.
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

March 22, 2013
April 2, 2013
September 2012
May 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01824641 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Physiologic Assessment of Thrombus Aspiration in Acute ST-segment Elevation Myocardial Infarction Patients
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Infarction
  • Device: Eliminate aspiration catheter
    Eliminate aspiration catheter
  • Procedure: Conventional primary angioplasty
    Primary angioplasty without thrombus aspiration
  • Experimental: Eliminate
    Eliminate aspiration catheter
    Intervention: Device: Eliminate aspiration catheter
  • Active Comparator: Conventional primary angioplasty
    Patients treated with conventional primary angioplasty
    Intervention: Procedure: Conventional primary angioplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
128
November 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
19 Years to 90 Years
No
Contact: Dejan Milasinovic, MD +381113613653 dejan_milasinovic@yahoo.com
Contact: Goran Stankovic, MD, PhD +381113615433 gorastan@sbb.rs
Serbia
 
NCT01824641
T113E4
Yes
Dejan Orlic, Clinical Centre of Serbia
Clinical Centre of Serbia
  • Center of nuclear medicine
  • Institute for histology
Principal Investigator: Dejan Orlic, MD Clinical Center of Serbia
Clinical Centre of Serbia
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP