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Coronary heart disease (CHD) is a public health care challenge. There are three types of treatment for CHD, medication, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, some end-stage CHD patients lost the chance to get those treatment. Cardiac shock wave therapy (CSWT) is a new developed therapy for these patients, which is used in tens of countries all over the world. Safety, invasiveness, effectiveness is its advantage. Ischemia condition can be improved after CSWT. There are only three cities in China run the program of CSWT, which are Kunming, Beijing and Shanghai. The investigators designed a randomized double-blind study to evaluate the effectiveness and safety of CSWT.
Coronary heart disease (CHD) is a public health care challenge, which lead to 3.5 millions of people died in China every year. There are three types of treatment for CHD, medication, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, some end-stage CHD patients with severe cardiac ischemia lost the chance to get those treatment. Their quality of life is influenced by recurrent angina. Cardiac shock wave therapy (CSWT) is a new developed therapy for these patients, which is used in tens of countries all over the world. German and Japan are the countries earliest used CSWT. Safety, invasiveness, effectiveness is its advantage. Ischemia condition can be improved after CSWT by objective examination. New small vessels generation on ischemia area was found on mice and pig model. There are only three cities in China run the program of CSWT, that are Kunming, Beijing and Shanghai. Beijing hospital has the only CSWT machine in Beijing. The investigators designed a randomized double-blind study to evaluate the effectiveness and safety of CSWT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSWT group | Experimental | Patients in CSWT group will receive cardiac shock wave therapy for three moths, every first week of the month. |
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| Sham CSWT group | Sham Comparator | Patients in sham CSWT group will receive sham cardiac shock wave, which segregated by an air-cushion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac shock wave therapy | Device | Patients in CSWT group will receive CSWT for a 3-month therapy, located in their ischemia area with a energy of 0.09mJ/mm2. Patients will get therapy on every first week of the month and rest for following three weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial perfusion score | Myocardial perfusion score will be calculated by myocardial perfusion imaging though single-photon computer tomography. | 1st week of fourth month from beginning of CSWT |
| Ischemia area percentage | Ischemia area will be calculated by myocardial perfusion imaging though single-photon computer tomography. | 1st week of fourth month from beginning of CSWT |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac wall motion amplitude | Cardiac wall motion amplitude rate will be calculated by single-photon computer tomography. | 1st week of fourth month from beginning of CSWT |
| Left ventricular thickness rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qing He | Beijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24802592 | Background | Yu W, Shen T, Liu B, Wang S, Li J, Dai D, Cai J, He Q. Cardiac shock wave therapy attenuates H9c2 myoblast apoptosis by activating the AKT signal pathway. Cell Physiol Biochem. 2014;33(5):1293-303. doi: 10.1159/000358697. Epub 2014 Apr 28. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Sham cardiac shock wave (Control group) | Other | Patients in sham CSWT group will receive sham cardiac shock wave, which is segregated by an air cushion. |
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Left ventricular thickness rate will be calculated by single-photon computer tomography.
| 1st week of fourth month from beginning of CSWT |
| Cardiac enzyme | Troponin T and troponin I will be tested at last time shock wave therapy of the first week. | First week after CSWT |
| Angina score-SAQ | SAQ angina score will be finished after three month of CSWT. | 1st week of fourth month from beginning of CSWT |
| Quality of life (SF-36) | SF-36 questionnaire will be used for QOL. | 1st week of fourth month from beginning of CSWT |
| Six-minute of walk test | 6MWT will be used for exertional capacity. | 1st week of fourth month from beginning of CSWT |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D008722 | Methods |