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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myocardin test group | Experimental | 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. |
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| Blank test group | No Intervention | Patients in blank test group aren't given the injection of cardiomyopeptidinl before primary percutaneous coronary intervention (PCI) . |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardiomyopeptidin | Drug | The main component of cardiomyopeptidin is the peptide active substance extracted from the ventricular myocytes of healthy young pigs. |
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| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarct size | Nuclear magnetic imaging focused on the assessment of myocardial infarct size(%); | 7±3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Delay enhancement | Nuclear magnetic imaging focused on microcirculation obstruction, myocardial edema area, delayed enhancement | 7±3 days after surgery |
| ECG ST-T changes | Interpretation of ST-T changes in leads based on electrocardiogram |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Geng Qian | Contact | 13810914587 | zouzouyuting@163.com | |
| Kai Yan | Contact | 13940849959 | ykanna_715@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yundai Chen | cardiology | Study Director |
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| ID | Term |
|---|---|
| C470986 | cardiomyopeptidin |
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Random, controlled, single blind
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| "hour6", "hour12","hour24"after myocardial infarction |
| Heart function classification | Cardiac function grading of patients with acute myocardial infarction by Killip grading | "day6", "week4","week12","week24"after surgery |
| CK(ng/ml) | one of Myocardial enzymes CK-MB(ng/ml)、cTnT(ng/ml)、BNP(pg/ml) | "hour6", "hour12","hour24" and 7±3 days after myocardial infarction |
| CK-MB(ng/ml) | one of Myocardial enzymes cTnT(ng/ml)、BNP(pg/ml) | "hour6", "hour12","hour24" and 7±3 days after myocardial infarction |
| cTnT(ng/ml) | one of Myocardial enzymes | "hour6", "hour12","hour24" and 7±3 days after myocardial infarction |
| BNP(pg/ml) | one of Myocardial enzymes | "hour6", "hour12","hour24" and 7±3 days after myocardial infarction |
| Cardiac echocardiography | Left ventricular ejection fraction | 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 | 7±3 days and 1,3,6 monthes after myocardial infarction |