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

The Effect of Cardiac Shock Wave Therapy in the Treatment of Myocardial Infarction With Non-obstructive Coronary Arteries: a Prospective, Randomized Controlled Clinical Study

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction With Non-obstructive Coronary Arteries; Cardiac Shock Wave Therapy
• Intervention / Treatment: Device: Cardiac Shock Wave Therapy

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 Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weijing Liu, MD, PhD; Phone Number: +86 18917684041; Email: liuweijing98@sina.com
• Study Contact Backup: Name: Ting Wang, MSc; Phone Number: +86 18260055217; Email: wt843238786@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Department of Cardiology, Shanghai Tenth People's Hospital
      • Contact: Weijing Liu, PhD; Phone Number: +86 189 1768 4041; Email: liuweijing98@sina.com
      • Principal Investigator: Yawei Xu, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline peak oxygen consumption at 6 months	maximum kilogram oxygen uptake accessed during Cardiopulmonary Exercise Testing (CPET)	1 day of inclusions and 6 months after the first treatment.
Change from baseline myocardial marker at 6 months	creatine kinase phosphate-isozyme (CK-MB) in blood samples	1 day of inclusions and 6 months after the first treatment.
Change from baseline hepatorenal function indexes at 6 months	alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum creatinine (SCr) in blood samples	1 day of inclusions and 6 months after the first treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events (MACE)	cardiovascular death, non-fatal myocardial infarction, unplanned coronary revascularization, stroke, heart failure, and angina-related rehospitalization	From the date of inclusion until the date of documented adverse events with 6 months
Other treatment-related adverse reactions		From the date of inclusion until the date of treatment-related adverse reactions within 6 months

Collaborators and Investigators

• Sponsor: Ya-Wei Xu
• Collaborators: Science and Technology Commission of Shanghai Municipality

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): June 20, 2025

Study Registration Dates

• First Submitted: June 4, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: myocardial infarction; cardiac shock wave therapy; D-SPECT; myocardial infarction with non-obstructive coronary arteries
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Shock; MINOCA
• Other Study ID Numbers: CSWT-MINOCA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No