ST-segment Elevation Myocardial Infarction
Conditions
Brief summary
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
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.
Interventions
PROCEDUREpercutaneous coronary intervention (PCI)
percutaneous coronary intervention (PCI) by stent implantation
DEVICEthrombus aspiration
thrombus aspiration with export catheter
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events | 1 year | number of participants with cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with stent thrombosis | 1 year | number of participants with stent thrombosis |
| Number of participants with target vessel revascularization | 1 year | number of participants with target vessel revascularization |
| left ventricular function | 1 year | left ventricular ejection fraction evaluated by ultrasound |
| Seattle Angina Questionnaire scores | 1 year | Seattle Angina Questionnaire scores |
| 6-minute walk distance (6MWD) | 1 year | 6-minute walk distance (6MWD) |
Countries
China
Contacts
Primary ContactDongdong Sun, M.D.,Ph.D.
Outcome results
None listed