Beijing Hospital
Beijing, Beijing Municipality, 100730, China
NCT Number: NCT03053128
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.
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100730, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: CSWT group
Patients in sham CSWT group will receive sham cardiac shock wave, which is segregated by an air cushion.
Other names: Sham CSWT group
Time frame: 1st week of fourth month from beginning of CSWT
Myocardial perfusion score will be calculated by myocardial perfusion imaging though single-photon computer tomography.
Time frame: 1st week of fourth month from beginning of CSWT
Ischemia area will be calculated by myocardial perfusion imaging though single-photon computer tomography.
Time frame: 1st week of fourth month from beginning of CSWT
Cardiac wall motion amplitude rate will be calculated by single-photon computer tomography.
Time frame: 1st week of fourth month from beginning of CSWT
Left ventricular thickness rate will be calculated by single-photon computer tomography.
Time frame: First week after CSWT
Troponin T and troponin I will be tested at last time shock wave therapy of the first week.
Time frame: 1st week of fourth month from beginning of CSWT
SAQ angina score will be finished after three month of CSWT.
Time frame: 1st week of fourth month from beginning of CSWT
SF-36 questionnaire will be used for QOL.
Time frame: 1st week of fourth month from beginning of CSWT
6MWT will be used for exertional capacity.
Beijing Hospital
Other Gov
Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease: A Prospective Randomized Double-blind Control Trial
Acronym: CSWT
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