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.