Clinical trial NCT01824641: Physiologic Assessment of Thrombus Aspiration in Acute ST-segment Elevation Myocardial Infarction Patients
Official title: The Randomized Physiologic Assessment of Thrombus Aspiration in Patients With Acute ST-segment Elevation Myocardial Infarction Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myocardial Infarction
Keywords: Acute myocardial infarction
Manual thrombus aspiration
Coronary physiology
Lead sponsor: Clinical Centre of Serbia
Sponsor class: OTHER
Collaborators: name: Center of nuclear medicine
name: Institute for histology
First posted: 2013-04-05
Enrollment: 128
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: IMR (mmHg seconds) in thrombus aspiration compared to conventional PCI group
timeFrame: At the end of the primary PCI , an expected average of 45 minutes after sheath insertion
Secondary outcomes:
measure: Resolution of ST-segment elevation
timeFrame: at 60 minutes after guiding catheter removal
measure: myocardial blush grade (0-3)
timeFrame: at final angiogram, an expected average of 55 minutes after sheath insertion
measure: infarct size assessed by peak enzyme release (Troponin, creatine kinase MB (CK-MB))
timeFrame: in hospital course after primary PCI, an expected average of 5 days
measure: indices of left ventricle remodeling on Echocardiography
timeFrame: within 24 hours and at 4 months after primary PCI
measure: infarct size determined by SPECT
timeFrame: within 7-14 days and at 4 months after primary PCI
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinical center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
Study officials:
affiliation: Clinical Center of Serbia
name: Dejan Orlic, MD
role: PRINCIPAL_INVESTIGATOR
References: