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

Primary Purpose

Myocardial Reperfusion Injury, Treatment Outcome, Prognosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Extracorporeal cardiac shock wave therapy(ECSW)
Sponsored by
First Affiliated Hospital of Kunming Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Reperfusion Injury focused on measuring extracorporeal cardiac shock waves, Endothelial progenitor cell, miR-140-3p

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Extracorporeal cardiac shock wave therapy was performed(ECSW)

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

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Expression level of miR-140-3p
    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
    All-cause mortality 2 years after surgery
    cardiac death
    Cardiac death 2 years after surgery
    Myocardial infarction (MI)
    Myocardial infarction 2 years after surgery
    Cerebrovascular accident (CVA)
    Cerebrovascular accident 2 years after surgery
    Major adverse cardiocerebral event (MACCE): death, MI, CVA, or any revascularization
    Major adverse cardiac and cerebral events 2 years after surgery

    Full Information

    First Posted
    November 3, 2022
    Last Updated
    November 12, 2022
    Sponsor
    First Affiliated Hospital of Kunming Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05624203
    Brief Title
    Clinical Efficacy of Extracorporeal Cardiac Shock Wave Therapy in Patients With Ischemia-reperfusion Injury
    Acronym
    CEECSWIRI
    Official Title
    Clinical Efficacy of Extracorporeal Cardiac Shock Wave Therapy in Patients With Ischemia-reperfusion Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First Affiliated Hospital of Kunming Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Reperfusion Injury, Treatment Outcome, Prognosis, ST Elevation Myocardial Infarction
    Keywords
    extracorporeal cardiac shock waves, Endothelial progenitor cell, miR-140-3p

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Extracorporeal cardiac shock wave therapy was performed(ECSW)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Extracorporeal cardiac shock wave therapy was not performed(NO ECSW)
    Arm Type
    No Intervention
    Arm Description
    Patients with acute ST-segment elevation myocardial infarction undergoing Percutaneous coronary intervention (PCI) are not treated with extracorporeal cardiac shock wave
    Intervention Type
    Device
    Intervention Name(s)
    Extracorporeal cardiac shock wave therapy(ECSW)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    A composite of death, myocardial infarction, or cerebrovascular events
    Description
    24 months after the index procedure
    Time Frame
    24months
    Secondary Outcome Measure Information:
    Title
    Expression level of miR-140-3p
    Description
    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
    Time Frame
    1, 2, 3, 6, 12 and 24 months
    Title
    All cause Death
    Description
    All-cause mortality 2 years after surgery
    Time Frame
    2 years
    Title
    cardiac death
    Description
    Cardiac death 2 years after surgery
    Time Frame
    2 years
    Title
    Myocardial infarction (MI)
    Description
    Myocardial infarction 2 years after surgery
    Time Frame
    2 years
    Title
    Cerebrovascular accident (CVA)
    Description
    Cerebrovascular accident 2 years after surgery
    Time Frame
    2 years
    Title
    Major adverse cardiocerebral event (MACCE): death, MI, CVA, or any revascularization
    Description
    Major adverse cardiac and cerebral events 2 years after surgery
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    li Xian-bin, master
    Phone
    +8618469110649
    Email
    kmykdx@yeah.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    ma Yi-ming, Dr.
    Phone
    +8615198810061
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cai Hongyan, Dr.
    Organizational Affiliation
    First Affiliated Hospital of Kunming Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Clinical Efficacy of Extracorporeal Cardiac Shock Wave Therapy in Patients With Ischemia-reperfusion Injury

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