STEMI - ST Elevation Myocardial Infarction
Conditions
Brief summary
To evaluate the influence of Salvianolate injection on myocardial microcirculation perfusion in subjects with STEMI who underwent primary PCI
Detailed description
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.
Interventions
DRUGNormal saline
Patients will be assigned to receive 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days.
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.
Sponsors
Green Valley Group of China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed consent must be obtained prior to any study procedure. 2. Age\>18 years. 3. Subjects of STEMI who underwent primary PCI within the first 12 hours.
Exclusion criteria
1. Allergic to Salvianolate injection 2. Mechanical complications 3. History of severe renal or hepatic insufficiency 4. Pregnant or breastfeeding women 5. Pool compliance,greater risks result from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TIMI flow grade | an average of 2 hours | Use TIMI flow grade to evaluate myocardial circulation perfusion |
| TIMI myocardial perfusion grade | an average of 2 hours | Use TIMI myocardial perfusion grade to evaluate myocardial circulation perfusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ST-segment resolution | up to 90 minutes | Use ST-segment resolution to evaluate the epicardial blood flow perfusion |
| myocardial contrast echocardiograph | up to 7 days | Use myocardial contrast echocardiograph to evaluate the myocardial microcirculation perfusion |
| creatine kinase isoenzyme | up to 48 hours | Use creatine kinase isoenzyme to evaluate myocardial infarct size |
| major adverse cardiovascular events | an average of 30 days | all-caused death, re-infarction, target vessel revascularization, stroke |
Countries
China
Contacts
Primary ContactHongying Liu, doctor
Outcome results
None listed