Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease: A Prospective Randomized Double-blind Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Myocardial perfusion score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Myocardial perfusion score
时间窗: 1st week of fourth month from beginning of CSWT
Myocardial perfusion score will be calculated by myocardial perfusion imaging though single-photon computer tomography.
Ischemia area percentage
时间窗: 1st week of fourth month from beginning of CSWT
Ischemia area will be calculated by myocardial perfusion imaging though single-photon computer tomography.
次要结局
- Quality of life (SF-36)(1st week of fourth month from beginning of CSWT)
- Six-minute of walk test(1st week of fourth month from beginning of CSWT)
- Cardiac wall motion amplitude(1st week of fourth month from beginning of CSWT)
- Cardiac enzyme(First week after CSWT)
- Angina score-SAQ(1st week of fourth month from beginning of CSWT)
- Left ventricular thickness rate(1st week of fourth month from beginning of CSWT)
研究者
Qing He
Cinical professor and Principal investigator
Beijing Hospital