Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease (CSWT)

Beijing Hospital

Status: Completed

Conditions: Cardiac Ischemia

Treatments: Other: Sham cardiac shock wave (Control group); Device: Cardiac shock wave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03053128

121-2016004

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Multiple or diffused coronary artery stenosis by coronary angiography and not candidate for PCI or CABG;
2. Myocardial ischemia and/or cardiac dysfunction by objective exams;
3. Angina and/or heart failure could not be control after optimal medication treatment for coronary artery disease;
4. LVEF is above 30%;
5. Signed informed consent

Exclusion criteria

1. Acute myocardial infarction;
2. Within one month after PCI or CABG;
3. Heart transplant patient;
4. Mechanic valve implantation patient;
5. Uncontrolled heart failure with LVEF less than 30%;
6. Severe arrhythmia;
7. Pacemaker implantation patient;
8. Infective endocarditis;
9. Severe chronic obstructive pulmonary disease patient;
10. Pregnant or nursing patient;
11. Silicone breast forms patient;
12. Chest tumor patient;
13. Participant in other clinical trials at the same time.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

CSWT group

Experimental group

Description:

Patients in CSWT group will receive cardiac shock wave therapy for three moths, every first week of the month.

Treatment:

Device: Cardiac shock wave therapy

Sham CSWT group

Sham Comparator group

Description:

Patients in sham CSWT group will receive sham cardiac shock wave, which segregated by an air-cushion.

Treatment:

Other: Sham cardiac shock wave (Control group)