Cardiac Shock Wave Therapy for the Treatment of Myocardial Infarction With Non-obstructive Coronary Arteries
NCT ID: NCT05935436
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
56 participants
INTERVENTIONAL
2023-07-01
2025-06-20
Brief Summary
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The prospective trial aimed to verify the safety and effectiveness of cardiac shock wave therapy (CSWT) in the treatment of Myocardial infarction with non-obstructive coronary arteries (MINOCA), and to expand the scope of clinical indications for CSWT and provide new treatment strategy for MINOCA.
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Detailed Description
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The exclusion criteria include: 1) Previous history of coronary heart disease, received percutaneous coronary intervention, coronary artery bypass surgery or myocardial infarction (MI); 2) Hemodynamic instability; 3) Acute heart failure; 4) Severe valvular heart disease requiring surgical treatment; 5) Severe liver and kidney diseases; 6) Malignant tumors with an expected survival of less than one year; 7) Patients with severe bleeding tendency; 8) Pregnant women; 9) Intervening coronary ischemic events.
Based on the literature and the number of participants with myocardial infarction in the hospital, the sample size calculated according to the formula is about 50 cases. Considering the dropout rate of 10%, the sample size should be 56 cases.
56 patients are randomly divided 1:1 by computer into the CSWT group and Control group, with 28 MINOCA participants in each group. Participants in the CSWT group are treated with conventional medical therapy (including antiplatelet drugs, statins, and antianginal drugs), combined with CSWT, and those in the Control group were treated with conventional medical therapy and sham CSWT. Care providers and physicians who follow participants (parameters of this study) should be blinded to group assignment. CSWT is performed according to the recommended protocol on shock wave output and the number of shots delivered per point developed by Tohoku University, Japan, and with protocol equipment (Modulith SLC; Storz Medical, Switzerland) developed by the University of Essen, Germany. CSWT is performed three times a week (days 1, 3, and 5) in a session with a 3-month interval between sessions or 1-month intensive treatment. 40 The participants underwent CSWT for 3 months and 9 CSWT sessions were performed in total. Participants in the control group received sham CSWT, the energy of cardiac shock wave therapy was the lowest, and the water bladder was in contact with the skin but not close to the skin.
Examinations in this prospective trial include D-SPECT, blood biochemical examination, myocardial marker, and cardiopulmonary exercise testing. During follow-up, investigators will record major adverse cardiovascular events, and adverse events caused by other treatments. The safety and effectivity of CSWT will be verified by clinical parameters, D-SPECT, and peak oxygen consumption in CPET.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CSWT Group
CSWT is performed three times a week (days 1, 3, and 5) in a session with a 3-month interval between sessions or 1-month intensive treatment.
Cardiac Shock Wave Therapy
When operating CSWT, it is necessary to determine the target myocardium for treatment, adjust the height of the water bladder, set the energy that the patient can tolerate, and then start the treatment. During the treatment, the vital signs of the subjects should be detected.
Control Group
Patients in the control group receive sham CSWT, the energy of cardiac shock wave therapy was the lowest, and the water bladder was in contact with the skin but not close to the skin.
Cardiac Shock Wave Therapy
When operating CSWT, it is necessary to determine the target myocardium for treatment, adjust the height of the water bladder, set the energy that the patient can tolerate, and then start the treatment. During the treatment, the vital signs of the subjects should be detected.
Interventions
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Cardiac Shock Wave Therapy
When operating CSWT, it is necessary to determine the target myocardium for treatment, adjust the height of the water bladder, set the energy that the patient can tolerate, and then start the treatment. During the treatment, the vital signs of the subjects should be detected.
Eligibility Criteria
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Inclusion Criteria
* The initial diagnosis is acute myocardial infarction
* Coronary angiography shows coronary stenosis \<50%
* Abnormal D-SPECT myocardial perfusion images
* Voluntary informed consent signed
Exclusion Criteria
* Hemodynamic instability
* Acute heart failure
* Severe valvular heart disease requiring surgical treatment
* Severe liver and kidney diseases
* Malignant tumors with expected survival of less than one year
* Patients with severe bleeding tendency
* Pregnant women
* Intervening coronary ischemic events
18 Years
85 Years
ALL
No
Sponsors
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Shanghai Municipal Science and Technology Commission
OTHER_GOV
Ya-Wei Xu
OTHER
Responsible Party
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Ya-Wei Xu
Chief Physician
Locations
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Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CSWT-MINOCA
Identifier Type: -
Identifier Source: org_study_id
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