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
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedFirst Posted
Study publicly available on registry
July 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2025
CompletedNovember 18, 2023
November 1, 2023
1.6 years
June 4, 2023
November 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change from baseline peak oxygen consumption at 6 months
1 day of inclusions and 6 months after the first treatment.
Change from baseline myocardial marker at 6 months
1 day of inclusions and 6 months after the first treatment.
Change from baseline hepatorenal function indexes at 6 months
1 day of inclusions and 6 months after the first treatment.
Other Outcomes (2)
Major adverse cardiovascular events (MACE)
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
Study Arms (2)
CSWT Group
ACTIVE COMPARATORCSWT 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.
Control Group
SHAM COMPARATORPatients 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.
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ya-Wei Xulead
- Shanghai Municipal Science and Technology Commissioncollaborator
Study Sites (1)
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
June 4, 2023
First Posted
July 7, 2023
Study Start
July 1, 2023
Primary Completion
January 31, 2025
Study Completion
June 20, 2025
Last Updated
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share