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Cardiac Shock Wave Therapy for the Treatment of Myocardial Infarction With Non-obstructive Coronary Arteries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05935436
Recruitment Status : Recruiting
First Posted : July 7, 2023
Last Update Posted : November 18, 2023
Sponsor:
Collaborator:
Science and Technology Commission of Shanghai Municipality
Information provided by (Responsible Party):
Ya-Wei Xu, Shanghai 10th People's Hospital

Study Description
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Brief Summary:

Myocardial infarction with non-obstructive coronary arteries (MINOCA) accounts for 15% of all myocardial infarctions and its mortality rate approaches that of large vessel myocardial infarction, but there are currently no effective treatment options. Coronary microvascular dysfunction is an important mechanism of MINOCA and is closely related to adverse cardiovascular outcomes.

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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction With Non-obstructive Coronary Arteries Cardiac Shock Wave Therapy Device: Cardiac Shock Wave Therapy Not Applicable

Detailed Description:

All participants will be fully informed of the study protocol, and informed consent will be obtained from each patient before the study. The inclusion criteria include: 1) Aged between 18 and 85 years old; 2) The initial diagnosis is acute myocardial infarction; 3) Coronary angiography shows coronary stenosis <50%; 4) Abnormal D-SPECT myocardial perfusion images; 5) Voluntary informed consent signed.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: The Effect of Cardiac Shock Wave Therapy in the Treatment of Myocardial Infarction With Non-obstructive Coronary Arteries: a Prospective, Randomized Controlled Clinical Study
Actual Study Start Date : July 1, 2023
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : June 20, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack Shock

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Device: 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.
Sham Comparator: 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.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline myocardial infarct area at 6 months [ Time Frame: 1 day of inclusions and 6 months after the first treatment. ]
    The location and extent of myocardial infarction were determined by D-SPECT.


Secondary Outcome Measures :
  1. Change from baseline peak oxygen consumption at 6 months [ Time Frame: 1 day of inclusions and 6 months after the first treatment. ]
    maximum kilogram oxygen uptake accessed during Cardiopulmonary Exercise Testing (CPET)

  2. Change from baseline myocardial marker at 6 months [ Time Frame: 1 day of inclusions and 6 months after the first treatment. ]
    creatine kinase phosphate-isozyme (CK-MB) in blood samples

  3. Change from baseline hepatorenal function indexes at 6 months [ Time Frame: 1 day of inclusions and 6 months after the first treatment. ]
    alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum creatinine (SCr) in blood samples


Other Outcome Measures:
  1. Major adverse cardiovascular events (MACE) [ Time Frame: From the date of inclusion until the date of documented adverse events with 6 months ]
    cardiovascular death, non-fatal myocardial infarction, unplanned coronary revascularization, stroke, heart failure, and angina-related rehospitalization

  2. Other treatment-related adverse reactions [ Time Frame: From the date of inclusion until the date of treatment-related adverse reactions within 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged between 18 and 85 years old
  • 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:

  • Previous history of coronary heart disease, received percutaneous coronary intervention, coronary artery bypass surgery or myocardial infarction (MI)
  • 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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05935436


Contacts
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Contact: Weijing Liu, MD, PhD +86 18917684041 liuweijing98@sina.com
Contact: Ting Wang, MSc +86 18260055217 wt843238786@163.com

Locations
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China, Shanghai
Department of Cardiology, Shanghai Tenth People's Hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: Weijing Liu, PhD    +86 189 1768 4041    liuweijing98@sina.com   
Principal Investigator: Yawei Xu, MD, PhD         
Sponsors and Collaborators
Ya-Wei Xu
Science and Technology Commission of Shanghai Municipality
More Information
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Responsible Party: Ya-Wei Xu, Chief Physician, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT05935436    
Other Study ID Numbers: CSWT-MINOCA
First Posted: July 7, 2023    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ya-Wei Xu, Shanghai 10th People's Hospital:
myocardial infarction with non-obstructive coronary arteries
cardiac shock wave therapy
D-SPECT
myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
MINOCA
Infarction
Shock
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases