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
- 发起方
- Medispec
- 入组人数
- 60
- 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-Echocardiography testing to identify the hypokinetic areas (ischemic areas). Following that, the ischemic areas sre treated with shockwaves. 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
- •Patient is diagnosed with chronic stable angina pectoris. Diagnosis is based on medical history, complete physical evaluation.
- •Patient has documented myocardial segments with reversible ischemia.
- •Patient is classified in AP CCS of III-IV.
- •Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
- •Patient demonstrates exercise tolerance capacity of no higher than 125 W on a modified Bruce treadmill exercise test until presence of clinical symptoms (i.e. angina, ST-depression).
- •Patient demonstrates exercise tolerance time and stability averaging no more than 25% of each other (the tests will be performed within two weeks and at least a day different between the two).
- •Patient has documented epicardial coronary artery disease not amenable to angioplasty or CABG.
- •Patient has signed an IRB approved informed consent form.
- •Patient's condition should be stable and should have a life expectancy of >12 months. Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's) medical opinion.
排除标准
- •Patient is pregnant
- •Patient has chronic lung disease including emphysema and pulmonary fibrosis.
- •Patient has active endocarditis, myocarditis or pericarditis.
- •Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization, or any ESWT machine of a competitor company within 3 months of entry into the study.
- •Patients who are unwilling or unable to cooperate with study procedure
结局指标
主要结局
Total Exercise Time
时间窗: 6 months
The primary efficacy endpoint is the change in maximal stress exercise capacity using the modified Bruce exercise test from baseline to the 6 months post-baseline assessment.
The incidence of adverse events at 12 months post treatment
时间窗: 15 months
Incidence of patient complications, adverse reactions and rise in cardiac enzymes, blood count, platelate count renal and hepatic function, and Troponin levels, as well as E.C.G. changes, 12 months post treatment.
次要结局
- Change in Seattle Angina Questionnaire (SAQ)(6 months)
- Change in AP-CCS(6 months)
- Change in the Number of angina attacks(6 months)
- Change in the Hospital Admission Rate(6 months)