Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease: A Prospective Randomized Double-blind Control Trial

Conditions
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Cardiac Ischemia

Intervention / Treatment
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* Device: Cardiac shock wave therapy
* Other: Sham cardiac shock wave (Control group)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multiple or diffused coronary artery stenosis by coronary angiography and not candidate for PCI or CABG; Myocardial ischemia and/or cardiac dysfunction by objective exams; Angina and/or heart failure could not be control after optimal medication treatment for coronary artery disease; LVEF is above 30%; Signed informed consent Exclusion Criteria: Acute myocardial infarction; Within one month after PCI or CABG; Heart transplant patient; Mechanic valve implantation patient; Uncontrolled heart failure with LVEF less than 30%; Severe arrhythmia; Pacemaker implantation patient; Infective endocarditis; Severe chronic obstructive pulmonary disease patient; Pregnant or nursing patient; Silicone breast forms patient; Chest tumor patient; Participant in other clinical trials at the same time.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSWT group<br>Patients in CSWT group will receive cardiac shock wave therapy for three moths, every first week of the month. | Device: Cardiac shock wave therapy<br>* 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.<br>* Other names: CSWT group;|
| Sham Comparator: Sham CSWT group<br>Patients in sham CSWT group will receive sham cardiac shock wave, which segregated by an air-cushion. | Other: Sham cardiac shock wave (Control group)<br>* Patients in sham CSWT group will receive sham cardiac shock wave, which is segregated by an air cushion.<br>* Other names: Sham CSWT group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac ischemia