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To evaluate the influence of Salvianolate injection on myocardial microcirculation perfusion in subjects with STEMI who underwent primary PCI
This is a prospective, randomized, double-blind and controlled study.536 subjects of STEMI who underwent primary PCI within the first 12 hours will be enrolled.all patients were assigned to receive 300mg of asprin and ≥300mg of clopidogrel as loading dose,and following 100mg and 75mg once daily respectively.Patients were assigned to receive Salvianolate injection or 0.9% sodium chloride injection in catherter room setting,and following similar medicine once daily respectively for 7 days.Myocardial circulation perfusion will be checked with mmediate coronary angiography parameters,ECG,echocardiographic,CK-MB.The major adverse cardiovascular events will be observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Patients will be assigned to receive 100ml of normal saline |
|
| Experimental group | Experimental | Patients will be assigned to receive Salvianolate injection dissolved in 100ml of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline | Drug | Patients will be assigned to receive 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| TIMI flow grade | Use TIMI flow grade to evaluate myocardial circulation perfusion | an average of 2 hours |
| TIMI myocardial perfusion grade | Use TIMI myocardial perfusion grade to evaluate myocardial circulation perfusion | an average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| ST-segment resolution | Use ST-segment resolution to evaluate the epicardial blood flow perfusion | up to 90 minutes |
| myocardial contrast echocardiograph | Use myocardial contrast echocardiograph to evaluate the myocardial microcirculation perfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongying Liu, doctor | Contact | yuyangxian021@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, doctor | Shanghai Zhongshan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | 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 |
|---|---|
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| C561960 | salvianolate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Salvianolate injection | Drug | Patients will be assigned to receive Salvianolate injection dissolved in 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days. |
|
|
| up to 7 days |
| creatine kinase isoenzyme | Use creatine kinase isoenzyme to evaluate myocardial infarct size | up to 48 hours |
| major adverse cardiovascular events | all-caused death, re-infarction, target vessel revascularization, stroke | an average of 30 days |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |