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| Name | Class |
|---|---|
| Center of nuclear medicine | UNKNOWN |
| Institute for histology | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eliminate | Experimental | Eliminate aspiration catheter |
|
| Conventional primary angioplasty | Active Comparator | Patients treated with conventional primary angioplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eliminate aspiration catheter | Device | Eliminate aspiration catheter |
| |
| Measure | Description | Time Frame |
|---|---|---|
| IMR (mmHg seconds) in thrombus aspiration compared to conventional PCI group | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of ST-segment elevation | ST-segment resolution ≥70% at 60 minutes after guiding catheter removal | at 60 minutes after guiding catheter removal |
| myocardial blush grade (0-3) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dejan Milasinovic, MD | Contact | +381113613653 | dejan_milasinovic@yahoo.com | |
| Goran Stankovic, MD, PhD | Contact | +381113615433 | gorastan@sbb.rs |
| Name | Affiliation | Role |
|---|---|---|
| Dejan Orlic, MD | Clinical Center of Serbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical center of Serbia | Recruiting | Belgrade | 11000 | Serbia |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Conventional primary angioplasty |
| Procedure |
Primary angioplasty without thrombus aspiration |
|
| 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)) | 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 | 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 | 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 |
| Clinical Center of Serbia | Recruiting | Belgrade | Serbia |
|
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |