Clinical Efficacy of Extracorporeal Cardiac Shock Wave Therapy in Patients With Ischemia-reperfusion Injury

First Affiliated Hospital of Kunming Medical University0 sites100 target enrollmentDecember 1, 2022

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 1, 2022

End Date

December 30, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

First Affiliated Hospital of Kunming Medical University

Responsible Party

Principal Investigator

Xian-bin li

Principal Investigator

First Affiliated Hospital of Kunming Medical University

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

A composite of death, myocardial infarction, or cerebrovascular events

Time Frame: 24months

24 months after the index procedure

Secondary Outcomes

cardiac death(2 years)
Cerebrovascular accident (CVA)(2 years)
Major adverse cardiocerebral event (MACCE): death, MI, CVA, or any revascularization(2 years)
Expression level of miR-140-3p(1, 2, 3, 6, 12 and 24 months)
All cause Death(2 years)
Myocardial infarction (MI)(2 years)