Myocardial Infarction
Conditions
Keywords
Acute myocardial infarction, Manual thrombus aspiration, Coronary physiology
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.
Interventions
DEVICEEliminate aspiration catheter
Eliminate aspiration catheter
PROCEDUREConventional primary angioplasty
Primary angioplasty without thrombus aspiration
Sponsors
Center of nuclear medicine
Institute for histology
Clinical Centre of Serbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IMR (mmHg seconds) in thrombus aspiration compared to conventional PCI group | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of ST-segment elevation | at 60 minutes after guiding catheter removal | ST-segment resolution ≥70% at 60 minutes after guiding catheter removal |
| myocardial blush grade (0-3) | 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 |
| infarct size assessed by peak enzyme release (Troponin, creatine kinase MB (CK-MB)) | 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 |
| indices of left ventricle remodeling on Echocardiography | 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 |
| infarct size determined by SPECT | 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 |
Countries
Serbia
Contacts
Primary ContactDejan Milasinovic, MD
Backup ContactGoran Stankovic, MD, PhD
Outcome results
None listed