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The goal of this clinical trial is to determine whether thrombus aspiration combined with percutaneous coronary intervention (PCI) improves clinical outcomes in ST-segment elevation myocardial infarction (STEMI) patients with high thrombus burden post-thrombolysis, compared to PCI alone. The study population includes 3500 STEMI patients, confirmed by diagnosis, who are transferred to PCI centers after receiving thrombolysis and have no contraindications to thrombolysis.The main questions it aims to answer are:
Participants will:
Undergo initial thrombolysis followed by transfer to PCI centers. Be randomly assigned in a 1:1 ratio to receive either thrombus aspiration combined with PCI or PCI alone.
Be followed for 30 days post-treatment to assess MACE and other clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thrombectomy + PCI Arm | Experimental | This group will receive thrombectomy combined with percutaneous coronary intervention. |
|
| PCI-only Arm | Active Comparator | PCI is an established treatment for STEMI, and you are comparing it to the experimental group that receives an additional thrombectomy procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombectomy | Procedure | Manual thrombectomy followed by Percutaneous Coronary Intervention (PCI), a procedure involving mechanical removal of thrombus before stent placement in coronary arteries to restore blood flow in STEM |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day Major Adverse Cardiovascular Events (MACE) | A composite of cardiovascular death, recurrent myocardial infarction, stroke, and rehospitalization for heart failure within 30 days post-intervention. | From enrollment to the end of treatment at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reperfusion Success | The percentage of patients achieving successful reperfusion as indicated by TIMI flow grade improvement (e.g., achieving TIMI 2 or 3 flow) after the intervention. | Within 30 minutes post-PCI (Percutaneous Coronary Intervention) |
| Follow-up MACE at 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shenghua Zhou | Contact | 073185292012 | zhoushenghua@csu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Surgery, The Second Xiangya Hospital of Central South University, No. 139, Middle Renmin Road, Changsha, 410011 Hunan, PR China | Recruiting | Changsha | Hunan | China |
all IPD that underlie results in a publication
Beginning 3 months and ending 3 years after the publication of results
To access the IPD and supporting information, interested parties should contact the principal investigator or designated study coordinator.
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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 |
|---|---|
| D017131 | Thrombectomy |
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D057510 | Endovascular Procedures |
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| Percutaneous Coronary Intervention | Procedure | Percutaneous Coronary Intervention, involving balloon angioplasty and stent placement to open blocked coronary arteries in STEMI patients after thrombolysis. |
|
The rate of major adverse cardiovascular events (including cardiovascular death, myocardial infarction, and stroke) occurring within 6 months post-intervention. |
| From enrollment to the end of treatment at 6 months |
| Follow-up all-cause mortality at 6 Months | The rate of all-cause mortality occurring within 6 months post-intervention. | From enrollment to the end of treatment at 6 months |
| Follow-up MACE at 12 Months | The rate of major adverse cardiovascular events (including cardiovascular death, myocardial infarction, and stroke) occurring within 12 months post-intervention. | From enrollment to the end of treatment at 12 months |
| Follow-up all-cause mortality at 12 Months | The rate of all-cause mortality occurring within 12 months post-intervention. | From enrollment to the end of treatment at 12 months |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D019060 | Minimally Invasive Surgical Procedures |