In this study, advanced techniques of myocardial nuclear magnetic perfusion scanning were used to quantitatively assess infarct size after acute myocardial infarction, saved viable myocardium, and microcirculatory obstruction area. Objectively and quantitatively evaluate early use of cardiomyopeptidin for direct PCI of ST-segment elevation myocardial infarction. After the improvement of microcirculation and increase the intervention effect of viable myocardium.
This is a prospective, randomized, controlled, single-blind, single-center clinical trial. Patients with ST-segment elevation myocardial infarction (STEMI) who were admitted in the People's Liberation Army General Hospital were equally randomized to receive either cardiomyopeptidin or placebo, and patients in cardiomyopeptidin group are given the injection of cardiomyopeptidinl before primary percutaneous coronary intervention (PCI) and intravenous infusion of cardiomyopeptidin was performed 3 days after primary PCI. Myocardial perfusion flow grade was evaluated by the result of primary PCI. Myocardial infarct size, microvascular obstruction and salvage myocardium were evaluated by enhanced cardiac magnetic resonance (CMR). Major adverse cardiovascular events (nonfatal myocardial infarction, all-cause death, hospitalization for acute heart failure, and revascularization for angina) were observed during the 6-month follow-up. CMR is performed to evaluate the effect of cardiomyopeptidin before primary PCI on myocardial salvage and microcirculation perfusion in patients with STEMI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
The main component of cardiomyopeptidin is the peptide active substance extracted from the ventricular myocytes of healthy young pigs.
Myocardial infarct size
Nuclear magnetic imaging focused on the assessment of myocardial infarct size(%);
Time frame: 7±3 days after surgery
Delay enhancement
Nuclear magnetic imaging focused on microcirculation obstruction, myocardial edema area, delayed enhancement
Time frame: 7±3 days after surgery
ECG ST-T changes
Interpretation of ST-T changes in leads based on electrocardiogram
Time frame: "hour6", "hour12","hour24"after myocardial infarction
Heart function classification
Cardiac function grading of patients with acute myocardial infarction by Killip grading
Time frame: "day6", "week4","week12","week24"after surgery
CK(ng/ml)
one of Myocardial enzymes CK-MB(ng/ml)、cTnT(ng/ml)、BNP(pg/ml)
Time frame: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction
CK-MB(ng/ml)
one of Myocardial enzymes cTnT(ng/ml)、BNP(pg/ml)
Time frame: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction
cTnT(ng/ml)
one of Myocardial enzymes
Time frame: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction
BNP(pg/ml)
one of Myocardial enzymes
Time frame: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction
Cardiac echocardiography
Left ventricular ejection fraction
Time frame: 3days and 1,3,6 monthes after myocardial infarction
Incidence of cardiovascular events
Non-lethal myocardial infarction, all-cause death, revascularization due to angina pectoris, re-hospitalization of acute heart failure
Time frame: 7±3 days and 1,3,6 monthes after myocardial infarction
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