Clinical Efficacy of Extracorporeal Cardiac Shock Wave Therapy in Patients With Ischemia-reperfusion Injury
- Conditions
- Myocardial Reperfusion InjuryPrognosisST Elevation Myocardial InfarctionTreatment Outcome
- Interventions
- Device: Extracorporeal cardiac shock wave therapy(ECSW)
- Registration Number
- NCT05624203
- Lead Sponsor
- First Affiliated Hospital of Kunming Medical University
- Brief Summary
This trial was a prospective, open-label, single-center, randomized trial, To observe the clinical efficacy of extracorporeal cardiac shock wave in the treatment of patients with myocardial ischemia-reperfusion injury and the difference in the level of endothelial progenitor cell-derived miR-140-3p in patients with myocardial ischemia-reperfusion injury treated with extracorporeal cardiac shock wave and control group and its relationship with clinical efficacy and prognosis. In order to provide a new therapy for patients with myocardial ischemia-reperfusion injury.
- Detailed Description
This trial was a prospective, open-label, single-center, randomized trial, To observe the clinical efficacy of extracorporeal cardiac shock wave in the treatment of patients with myocardial ischemia-reperfusion injury and the difference in the level of endothelial progenitor cell-derived miR-140-3p in patients with myocardial ischemia-reperfusion injury treated with extracorporeal cardiac shock wave and control group and its relationship with clinical efficacy and prognosis. In order to provide a new therapy for patients with myocardial ischemia-reperfusion injury.Patients with acute ST-segment elevation myocardial infarction who underwent coronary artery stenting (PCI) were randomly divided into extracorporeal cardiac shock wave treatment group and blank control group. The primary endpoint was to analyze the clinical symptoms, cardiac structure and function, coronary microcirculation, readmission rate, related score and prognosis between the two groups. The secondary end point was to draw the survival curve of the two groups according to the follow-up situation, and establish a Cox regression model to analyze whether the survival prognosis of patients was correlated with the expression level of miR-140-3p.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Age ≥18 years The patient was diagnosed with acute ST-segment elevation myocardial infarction for the first time, and coronary angiography showed moderate to severe coronary artery stenosis. PCI was performed within 12 hours of the onset of the disease according to the current guidelines, and postoperative hemodynamic stability was achieved CCS angina pectoris grade Ⅱ or above, NYHA cardiac function grade I-Ⅲ Imaging examination [stress echocardiography and/or stress myocardial perfusion imaging] suggested objective evidence of reversible myocardial ischemia Voluntary participation, able to cooperate with treatment and follow-up, signed informed consent.
severe unprotected left main stem lesions Left ventricular systolic function was impaired with hemodynamic instability chronic obstructive pulmonary disease, pulmonary maculopathy, post-pseudobulbar placement or other causes of poor sonographic window Combined with chest malignant tumor pregnancy The skin of the treatment area is broken or infected NYHA cardiac function grade Ⅳ Acute myocarditis, pericarditis, moderate or large amount of pericardial effusion, infective endocarditis, deep vein thrombosis, intracardiac thrombosis; Severe aortic stenosis, aortic aneurysm, thoracic aortic dissection, thoracic aortic aneurysm, after heart transplantation, metal heart valve replacement, pulmonary embolism patients undergoing thrombolysis and surgical bypass Patients with a history of mental illness, poor compliance and inability to cooperate.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extracorporeal cardiac shock wave therapy was performed（ECSW） Extracorporeal cardiac shock wave therapy(ECSW) Patients with acute ST-segment elevation myocardial infarction who underwent Percutaneous coronary intervention (PCI) were treated with extracorporeal cardiac shock wave therapy 2-3 days after operation. The duration of treatment was 3 months, and 9 treatments were completed within 3 months as a course. One week of treatment was followed by a 3-week rest in each month. CSWT was performed three times in each treatment week, respectively on the 1st, 3rd, and 5th day of the treatment week, for a total of 3 months.
- Primary Outcome Measures
Name Time Method A composite of death, myocardial infarction, or cerebrovascular events 24months 24 months after the index procedure
- Secondary Outcome Measures
Name Time Method cardiac death 2 years Cardiac death 2 years after surgery
Cerebrovascular accident (CVA) 2 years Cerebrovascular accident 2 years after surgery
Major adverse cardiocerebral event (MACCE): death, MI, CVA, or any revascularization 2 years Major adverse cardiac and cerebral events 2 years after surgery
Expression level of miR-140-3p 1, 2, 3, 6, 12 and 24 months The expression levels of miR-140-3p in exosomes derived from endothelial progenitor cells (EPCs) were measured in peripheral blood collected from patients at 1, 2, 3, 6, 12 and 24 months
All cause Death 2 years All-cause mortality 2 years after surgery
Myocardial infarction (MI) 2 years Myocardial infarction 2 years after surgery