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

NCT ID: NCT05624203

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-12-30

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.

Conditions

Myocardial Reperfusion Injury; Treatment Outcome; Prognosis; ST Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Extracorporeal cardiac shock wave therapy(ECSW)

Intervention Type: DEVICE

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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xian-bin li

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cai Hongyan, Dr.

Role: STUDY_DIRECTOR

First Affiliated Hospital of Kunming Medical University

Central Contacts

li Xian-bin, master

Role: CONTACT

kmykdx@yeah.net

+8618469110649

ma Yi-ming, Dr.

Role: CONTACT

+8615198810061

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Other Identifiers

1stKunmingMCYN

Identifier Type: -

Identifier Source: org_study_id