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

Sponsor

The First Affiliated Hospital of Kunming Medical College (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05624203

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Myocardial Reperfusion Injury Treatment Outcome Prognosis ST Elevation Myocardial Infarction	Device: Extracorporeal cardiac shock wave therapy(ECSW)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients with acute ST-segment elevation myocardial infarction undergoing Percutaneous coronary intervention (PCI) were randomly divided into extracorporeal cardiac shock wave treatment group and blank control group.Patients with acute ST-segment elevation myocardial infarction undergoing Percutaneous coronary intervention (PCI) were randomly divided into extracorporeal cardiac shock wave treatment group and blank control group.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Extracorporeal cardiac shock wave therapy was performed（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.	Device: Extracorporeal cardiac shock wave therapy(ECSW) Extracorporeal cardiac shock wave therapy (CSWT) is a cutting-edge technology developed in the world for more than 20 years. It is mainly used in the treatment of refractory angina pectoris of coronary heart disease. The mechanism of extracorporeal cardiac shock wave therapy is mainly due to the small attenuation, small shear stress and strong penetration force of shock wave when propagating in human tissues. Shear stress and hole effect are generated in the focal area of shock wave, which leads to the repeated formation/rupture of microbubbles in tissue/cell microenvironment, resulting in various physical and biological effects. These physical mechanisms trigger a series of biological effects, such as promoting the expression of various intracellular cytokines and angiogenic factors, activating related signal transduction pathways, inhibiting apoptosis and oxidative stress, and finally increasing the number of new blood vessels in the treatment area and improving the ischemic state.
No Intervention: Extracorporeal cardiac shock wave therapy was not performed（NO ECSW） Patients with acute ST-segment elevation myocardial infarction undergoing Percutaneous coronary intervention (PCI) are not treated with extracorporeal cardiac shock wave

Arm

Intervention/Treatment

Experimental: Extracorporeal cardiac shock wave therapy was performed（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.

Device: Extracorporeal cardiac shock wave therapy(ECSW)

Extracorporeal cardiac shock wave therapy (CSWT) is a cutting-edge technology developed in the world for more than 20 years. It is mainly used in the treatment of refractory angina pectoris of coronary heart disease. The mechanism of extracorporeal cardiac shock wave therapy is mainly due to the small attenuation, small shear stress and strong penetration force of shock wave when propagating in human tissues. Shear stress and hole effect are generated in the focal area of shock wave, which leads to the repeated formation/rupture of microbubbles in tissue/cell microenvironment, resulting in various physical and biological effects. These physical mechanisms trigger a series of biological effects, such as promoting the expression of various intracellular cytokines and angiogenic factors, activating related signal transduction pathways, inhibiting apoptosis and oxidative stress, and finally increasing the number of new blood vessels in the treatment area and improving the ischemic state.

No Intervention: Extracorporeal cardiac shock wave therapy was not performed（NO ECSW）

Patients with acute ST-segment elevation myocardial infarction undergoing Percutaneous coronary intervention (PCI) are not treated with extracorporeal cardiac shock wave

Outcome Measures

Primary Outcome Measures

A composite of death, myocardial infarction, or cerebrovascular events [24months]
24 months after the index procedure

Secondary Outcome Measures

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
cardiac death [2 years]
Cardiac death 2 years after surgery
Myocardial infarction (MI) [2 years]
Myocardial infarction 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.