Improvement of Cardiac Function in Patients With Ischemic Cardiomyopathy by Extracorporeal Shock Wave Therapy: a Multicenter Clinical Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Canadian Cardiovascular Society (CCS) grading of angina
研究概览
简要总结
Cardiac shock wave therapy (CSWT) is a noninvasive new therapeutic option in the treatment of chronic refractory angina pectoris. Many domestic and international researches have revealed that CSWT contributes to revascularization by stimulating angiogenesis. We were aimed to evaluate the safety and efficiency of CSWT in the treatment of refractory angina.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were 18 to 80 years old;
- •Coronary angiography (CA) or multi-slice CT coronary angiography (CTCA) suggestive of moderate to severe coronary artery stenosis;
- •Chest tightness, onset of shortness of breath, and poor exercise tolerance after receiving formal drug treatment (with or without stent or bypass graft);
- •Hospitalized more than 2 times within 1 year due to the aforementioned problems;
- •CCS angina grading higher than grade II, and New York Heart Association (NYHA) class I-III;
- •More than 1 month after acute myocardial infarction (AMI) and 1 month after percutaneous coronary intervention (PCI) surgery.
排除标准
- •AMI、PCI or coronary artery bypass graft (CABG) within the 4 weeks prior to the study;
- •History of heart transplantation;
- •History of metal valve replacement surgery;
- •Intra-cardiac thrombus;
- •Left Ventricular Ejection Fraction (LVEF) < 30 % and unstable hemodynamics;
- •Arrhythmia with a rate < 40 bpm or > 120 bpm;
- •Skin ulceration or infection in the treatment area;
- •Severe obstructive lung disease.
研究组 & 干预措施
Cardiac shock wave therapy (CSWT) group
The CWST group were performed with a CSWT equipment (Storz Medical, Switzerland) followed the recommended protocol developed by Tohoku University of Japan with respect to the shockwave output and the number of shots implemented to each spot and the protocol developed by the University of Essen, Germany.
干预措施: Cardiac shock wave therapy (Device)
Control group
No CWST treatment.
结局指标
主要结局
Canadian Cardiovascular Society (CCS) grading of angina
时间窗: 6 months
questionnaire of Canadian Cardiovascular Society grading of angina concerning exercise tolerance
Seattle angina questions (SAQ)
时间窗: 6 months
questionnaire of Seattle angina questions to evaluate the effect of coronary artery disease on patients' life quality
6-min walk test
时间窗: 6 months
All participants will receive a 6 minutes' walk test to evaluate their effect of treatment of cardiac shock wave therapy
Nitrate consumption
时间窗: 6 months
All participants will receive a questionnaire of the amount of nitrate they need before and after treatment of cardiac shock wave therapy
次要结局
未报告次要终点
研究者
Ya-Wei Xu
Professor
Shanghai 10th People's Hospital