Randomized, Placebo Controlled, Double Blind Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Medispec
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Total Exercise Time
研究概览
简要总结
Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.
The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.
详细描述
Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to myocardial ischemic tissue. Shockwaves are created by a special generator and are focused using a shockwave applicator device. The treatment is guided by standard echocardiography equipment. The shockwaves are delivered in synchronization with Patient R-wave to avoid arrhythmias. The treatment is painless.
At first, the patient undergoes stress- SPECT testing to identify the ischemic areas. Following that, the same area is localized by the ultra-sound device and the shockwaves are focused to the ischemic area. Several treatments are required for optimal results.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with chronic stable angina pectoris.
- •Documented myocardial segments with reversible ischemia
- •AP CCS class of III-IV.
- •Stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
- •Exercise tolerance time < 10 min (modified Bruce)
- •Two ETT tests results (within two weeks) averaging no more than 25% of their mean
- •Documented epicardial coronary artery disease not amenable to angioplasty or CABG.
- •Signed an IRB approved informed consent form.
- •Life expectancy of >12 months.
排除标准
- •Intraventricular thrombus
- •Malignancy in the area of treatment
- •Severe COPD
- •No smoking during the study procedure
- •MI less <3 months prior to treatment
- •Severe Valvular disease
- •Child bearing potential
结局指标
主要结局
Total Exercise Time
时间窗: 6 months
次要结局
- Change in SPECT(6 months)
- Change in AP-CCS(6 months)