Thrombus Aspiration in Patients With STEMI

Study Overview
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Brief Summary
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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).

Detailed Description
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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). 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.

Official Title
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Safety and Efficacy of Thrombus Aspiration in Patients With ST-segment Elevation Myocardial Infarction (STEMI)

Conditions
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ST-segment Elevation Myocardial Infarction

Intervention / Treatment
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* Procedure: percutaneous coronary intervention (PCI)
* Device: thrombus aspiration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-80; Diagnosed as STEMI for presenting symptoms or definite ECG and myocardial markers changes; Patients presenting with definite ECG changes indicating STEMI: ST elevation of 0.1 mV in 2 contiguous limb leads or ≥0.2 mV in 2 contiguous precordial leads; Referred for PCI for presenting symptoms, and the coronary angiogram (CAG) shows that the initial TIMI thrombus grade ≥2; Informed consent. Exclusion Criteria: Previous history of myocardiopathy, valvular heart disease or severe heart failure; Severe hepatic or renal dysfunction; Life expectancy less than 1 year; Prior PCI or CABG; Contraindications of using anticoagulation or antiplatelet drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: thrombus aspiration with PCI<br>patient will receive manual thrombus aspiration with percutaneous coronary intervention (PCI) | Procedure: percutaneous coronary intervention (PCI)<br>* percutaneous coronary intervention (PCI) by stent implantation<br>* Other names: primary percutaneous coronary intervention (PCI);Device: thrombus aspiration<br>* thrombus aspiration with export catheter<br>* Other names: export catheter;|
| Active Comparator: PCI alone<br>patients will receive percutaneous coronary intervention (PCI) alone including stent implantation | Procedure: percutaneous coronary intervention (PCI)<br>* percutaneous coronary intervention (PCI) by stent implantation<br>* Other names: primary percutaneous coronary intervention (PCI);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |