Myocardial Infarction With Non-obstructive Coronary ArteriesNCT05935436
Cardiac Shock Wave Therapy for the Treatment of Myocardial Infarction With Non-obstructive Coronary Arteries
A study testing Cardiac Shock Wave Therapy in people with Myocardial Infarction With Non-obstructive Coronary Arteries and Cardiac Shock Wave Therapy, run by Ya-Wei Xu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Infarction With Non-obstructive Coronary Arteries, Cardiac Shock Wave Therapy
- What is being tested?
- Cardiac Shock Wave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients with severe bleeding tendency
- Pregnant women
- Intervening coronary ischemic events
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Weijing Liu, PhD, +86 189 1768 4041, liuweijing98@sina.com
Yawei Xu, MD, PhD
About this study
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
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.
Read the 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.
- Being tested
- Cardiac Shock Wave Therapy
- Keywords
- myocardial infarction with non-obstructive coronary arteries, cardiac shock wave therapy, D-SPECT, myocardial infarction
- Medical subject headings
- MINOCA, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Shock Wave TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CSWT Group | Active comparator | 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. Receives: Device: Cardiac Shock Wave Therapy |
| Control Group | Sham comparator | 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. Receives: Device: Cardiac Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline myocardial infarct area at 6 months
The location and extent of myocardial infarction were determined by D-SPECT.
Measured: 1 day of inclusions and 6 months after the first treatment.
Secondary outcomes (3)
Change from baseline peak oxygen consumption at 6 months
maximum kilogram oxygen uptake accessed during Cardiopulmonary Exercise Testing (CPET)
Measured: 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
Measured: 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
Measured: 1 day of inclusions and 6 months after the first treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Jul 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction With Non-obstructive Coronary ArteriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ya-Wei Xu
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Responsible party
- Sponsor-investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935436
- Sponsor's protocol ID
- CSWT-MINOCA
- Status last verified
- Nov 2023
- First submitted
- 4 Jun 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05935436
- Acronym / sponsor ID
- CSWT-MINOCA
- Keywords
- myocardial infarction with non-obstructive coronary arteries, cardiac shock wave therapy, D-SPECT, myocardial infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Ya-Wei XuUniversity, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSWT Group | Active comparator | Device: Cardiac Shock Wave TherapyCSWT 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 comparator | Device: Cardiac Shock Wave TherapyPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Shock Wave TherapyWhen 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. | Device | CSWT Group, Control Group |
Primary outcome
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.
3 secondary outcomes
Change from baseline peak oxygen consumption at 6 months
Time frame: 1 day of inclusions and 6 months after the first treatment.
Change from baseline myocardial marker at 6 months
Time frame: 1 day of inclusions and 6 months after the first treatment.
Change from baseline hepatorenal function indexes at 6 months
Time frame: 1 day of inclusions and 6 months after the first treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Shock Wave Therapy in people with Myocardial Infarction With Non-obstructive Coronary Arteries and Cardiac Shock Wave Therapy, run by Ya-Wei Xu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weijing Liu, MD, PhD (+86 18917684041, liuweijing98@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline myocardial infarct area at 6 months (time frame: 1 day of inclusions and 6 months after the first treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.