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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05935436
Other study ID # CSWT-MINOCA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date June 20, 2025

Study information

Verified date November 2023
Source Shanghai 10th People's Hospital
Contact Weijing Liu, MD, PhD
Phone +86 18917684041
Email liuweijing98@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date June 20, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Department of Cardiology, Shanghai Tenth People's Hospital Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Ya-Wei Xu Science and Technology Commission of Shanghai Municipality

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other 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 Other treatment-related adverse reactions From the date of inclusion until the date of treatment-related adverse reactions within 6 months
Primary 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 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.
Secondary 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.
Secondary 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.
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04974320 - Rapid Identification of MINOCA Based on Novel Biomarkers
Recruiting NCT05122780 - Prognostic Value of Precision Medicine in Patients With MINOCA (PROMISE Trial). Phase 4
Terminated NCT03686696 - Randomized Evaluation of Beta Blocker and ACEI/ARB Treatment in MINOCA Patients - MINOCA-BAT Phase 4