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This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI).
This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI). Patients who are diagnosed as STEMI and referred for PCI will be enrolled. They will be randomized 1:1 to either manual thrombus aspiration with PCI group or PCI alone group.The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure during 1 year follow-up. The secondary efficacy outcome are stent thrombosis, target vessel revascularization, left ventricular function and quality of life during 1 year follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| thrombus aspiration with PCI | Experimental | patient will receive manual thrombus aspiration with percutaneous coronary intervention (PCI) |
|
| PCI alone | Active Comparator | patients will receive percutaneous coronary intervention (PCI) alone including stent implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous coronary intervention (PCI) | Procedure | percutaneous coronary intervention (PCI) by stent implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | number of participants with cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with stent thrombosis | number of participants with stent thrombosis | 1 year |
| Number of participants with target vessel revascularization | number of participants with target vessel revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongdong Sun, M.D.,Ph.D. | Contact | 86 29 84775183 | wintersun3@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dongdong Sun, M.D.,Ph.D. | Air Force Military Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| thrombus aspiration | Device | thrombus aspiration with export catheter |
|
|
| 1 year |
| left ventricular function | left ventricular ejection fraction evaluated by ultrasound | 1 year |
| Seattle Angina Questionnaire scores | Seattle Angina Questionnaire scores | 1 year |
| 6-minute walk distance (6MWD) | 6-minute walk distance (6MWD) | 1 year |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D019060 | Minimally Invasive Surgical Procedures |