Multicentre, Randomized,Double Blind,Placebo Controlled Trial of Myocardial Angiogenesis Using VEGF165, Intramyocardial Gene Delivery in Patients With Severe Angina
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 14
- 主要终点
- Myocardial perfusion-stress/ rest scores(SRS),changes in summed stress scores(SSS)from baseline to 12 weeks follow up between placebo and VEGF treated groups. This analysis will be repeated at 6 months
研究概览
简要总结
To demonstrate the clinical efficacy and safety of vascular endothelial growth factor(VEGF165)when delivered by direct myocardial injection through the NOGA navigational catheter to improve myocardial perfusion in patients with severe angina pectoris for whom conventional PCI or CABG are either not possible or not ideal.Secondary objective will be to determine the effects of VEGF gene therapy on angina symptoms, patient perceived quality of life and exercise capacity
详细描述
A multicentre, double blind, placebo controlled trial to assess efficacy of VEGF and promote myocardial angiogenesis in patients with CCS III-IV angina symptoms,treated with maximal anti anginal medications who are not amenable to or not ideal candidates for conventional revascularization.
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Canadian Cardiovascular Class III-IV angina despite treatment with maximal medical therapy
- •LVEF>20%
- •Ischemic defects on myocardial stress SPECT imaging
排除标准
- •History of or diagnosis of age related macular degeneration, retinopathy
- •Atrial fibrillation
- •Primary valvular heart disease
- •Evidence of or known history of cancer with in past 10 yea
- •Uncontrolled hypertension
- •Liability to receive dipyridamole
- •History or diagnosis of rheumatoid arthritis
- •Recent MI(within 4 weeks)
- •Important ilio-femoral peripheral vascular disease, limiting catheter access
- •History of unexplained gastrointestinal hemorrhage with the past 5 years
- •LV thrombus visualized by either echocardiography or contrast LV angiogram
- •Other severe concurrent illnesses
结局指标
主要结局
Myocardial perfusion-stress/ rest scores(SRS),changes in summed stress scores(SSS)from baseline to 12 weeks follow up between placebo and VEGF treated groups. This analysis will be repeated at 6 months
次要结局
- symptom evaluation (CCS class, Seattle Angina Questionnaire; patient perceived Quality of Life( SF 36 questionnaire); exercise performance; major adverse cardiac events