Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute STEMI After Primary PCI

Study Overview
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Brief Summary
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To evaluate the influence of Salvianolate injection on myocardial microcirculation perfusion in subjects with STEMI who underwent primary PCI

Detailed Description
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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.

Official Title
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Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary PCI

Conditions
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STEMI - ST Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Normal saline
* Drug: Salvianolate injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent must be obtained prior to any study procedure. Age>18 years. Subjects of STEMI who underwent primary PCI within the first 12 hours. Exclusion Criteria: Allergic to Salvianolate injection Mechanical complications History of severe renal or hepatic insufficiency Pregnant or breastfeeding women Pool compliance,greater risks result from the study

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Patients will be assigned to receive 100ml of normal saline | Drug: Normal saline<br>* Patients will be assigned to receive 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days.<br>* Other names: 0.9% sodium chloride solution;|
| Experimental: Experimental group<br>Patients will be assigned to receive Salvianolate injection dissolved in 100ml of normal saline | Drug: Salvianolate injection<br>* 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.<br>* Other names: Salvianolate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |