A Randomized, Single-blind, Controlled Clinical Trial of Cardiomyopeptidin Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction Undergoing Direct PCI After Ischemia-reperfusion Injury
Overview
- Phase
- Phase 4
- Intervention
- cardiomyopeptidin
- Conditions
- Survival Myocardial Area After Acute Myocardial Death
- Sponsor
- Dalian Zhen-Ao Bio-Tech Co., Ltd.
- Enrollment
- 160
- Primary Endpoint
- Myocardial infarct size
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sign the informed consent form;
- •Age ≥ 18 and ≤ 80 years old, gender is not limited;
- •Defining the diagnosis of acute myocardial infarction, with indications for direct coronary intervention;
- •Ischemic chest pain lasts for more than 30 minutes and adjacent ST or 2 leads of more than 2 or more leads (limb lead ≥ 0.1 mV, chest lead ≥ 0.2 mV) with or without elevated myocardial enzyme levels ;
- •The course of disease is ≤12 hours or accompanied by cardiogenic shock or heart failure (onset \>12h).
Exclusion Criteria
- •(1) Cardiogenic shock, Killip III-IV grade, papillary muscle rupture, interventricular septal perforation, ventricular ventricular fibrillation and electrical cardioversion, and III degree AVB implantation of temporary pacemaker before PCI;
- •(2) LVEF ≤ 30%;
- •(3) Previous history of PCI and CABG history;
- •(4) acute and chronic infectious diseases (severe pneumonia, etc.);
- •(5) Recent history of hemorrhagic stroke (within six months);
- •(6) Combining liver and kidney dysfunction caused by various reasons;
- •(7) History of valvular heart disease;
- •(8) Congenital heart disease and pulmonary hypertension;
- •(9) History of various types of cardiomyopathy;
- •(10) bleeding and other thrombotic diseases;
Arms & Interventions
Myocardin test group
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.
Intervention: cardiomyopeptidin
Outcomes
Primary Outcomes
Myocardial infarct size
Time Frame: 7±3 days after surgery
Nuclear magnetic imaging focused on the assessment of myocardial infarct size（%）;
Secondary Outcomes
- CK-MB(ng/ml)("hour6", "hour12","hour24" and 7±3 days after myocardial infarction)
- cTnT(ng/ml)("hour6", "hour12","hour24" and 7±3 days after myocardial infarction)
- Delay enhancement(7±3 days after surgery)
- BNP(pg/ml)("hour6", "hour12","hour24" and 7±3 days after myocardial infarction)
- CK（ng/ml）("hour6", "hour12","hour24" and 7±3 days after myocardial infarction)
- Cardiac echocardiography(3days and 1,3,6 monthes after myocardial infarction)
- ECG ST-T changes("hour6", "hour12","hour24"after myocardial infarction)
- Heart function classification("day6", "week4","week12","week24"after surgery)
- Incidence of cardiovascular events(7±3 days and 1,3,6 monthes after myocardial infarction)